Multiple dressing negative pressure wound therapy system

ABSTRACT

Embodiments described herein relate to apparatuses, systems, and methods for the treatment of wounds, for example using multiple wound dressings in combination with negative pressure wound therapy. A negative pressure would therapy apparatus can include a negative pressure source and a controller. The negative pressure source can include inlets configured to couple via fluid flow paths to wound dressings. The fluid flow paths can include pressure sensors configured to measure pressure in the fluid flow paths. The pressure sensors can include a first pressure sensor configured to measure pressure in the first fluid flow path and a second pressure sensor configured to measure pressure in the second fluid flow path. The controller can be configured to operate the negative pressure source and provide, based on measured pressure, indication of at least one operating condition associated with at least one of the fluid flow paths.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/464,988, filed Feb. 28, 2017, entitled “MULTIPLE DRESSING NEGATIVEPRESSURE WOUND THERAPY SYSTEM,” U.S. Provisional Application No.62/464,992, filed Feb. 28, 2017, entitled “MULTIPLE DRESSING NEGATIVEPRESSURE WOUND THERAPY SYSTEM,” and U.S. Provisional Application No.62/465,011, filed Feb. 28, 2017, entitled “MULTIPLE DRESSING NEGATIVEPRESSURE WOUND THERAPY SYSTEM,” each of which is hereby incorporated byreference in its entirety.

BACKGROUND Technical Field

Embodiments described herein relate to apparatuses, systems, and methodsfor the treatment of wounds, for example using multiple wound dressingsin combination with negative pressure wound therapy.

Description of the Related Art

Negative pressure wound therapy (NPWT) promotes wound healing byfacilitating the formation of granulation tissue at the wound site andby assisting the body's normal inflammatory process while simultaneouslyremoving excess fluid, which may contain adverse cytokines and/orbacteria. However, existing NPWT systems are typically limited at leastbecause they are able to treat only one wound at a time. When existingNPWT systems are used for treating more than one wound, this results inineffective and imprecise treatment. Accordingly, further improvementsin NPWT are needed to fully realize the benefits of treatment.

SUMMARY

In some embodiments, a negative pressure would therapy apparatusincludes a negative pressure source, a plurality of pressure sensors,and a controller. The negative pressure source includes a plurality ofinlets configured to couple via a plurality of fluid flow paths to aplurality of wound dressings and provide negative pressure to theplurality of wound dressings. The plurality of fluid flow paths includea first fluid flow path configured to fluidically connect a first wounddressing to a first inlet of the plurality of inlets, and a second fluidflow path configured to fluidically connect a second wound dressing to asecond inlet of the plurality of inlets. The plurality of pressuresensors are configured to measure pressure in the plurality of fluidflow paths. The plurality of pressure sensors include a first pressuresensor configured to measure pressure in the first fluid flow path, anda second pressure sensor configured to measure pressure in the secondfluid flow path. The controller is configured to operate the negativepressure source and provide, based on pressure measured by at least oneof the first or second pressure sensors, indication of at least oneoperating condition associated with at least one of the first or secondfluid flow paths.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. At least one operating condition can include ablockage, a leakage, an overpressure, or a dressing full condition. Theapparatus can further include a housing configured to support thenegative pressure source and the first and second inlets. The firstfluid flow path can include a first identifier configured to indicate toa user a fluidic connection between the first wound dressing and thenegative pressure source. The second fluid flow path can include asecond identifier configured to indicate to the user a fluidicconnection between the second wound dressing and the negative pressuresource. The first and second identifiers can include at least one of aprinted glyph, a printed icon, an embossed glyph, an embossed icon, abraille character, or a color coding. The first and second identifierscan be positioned proximate the inlet manifold branching attachment. Thecontroller can be further configured to provide a first indicationassociated with an operating condition in the first fluid flow path anda second indication associated with an operating condition in the secondfluid flow path. The first and second indications can be one or more ofvisual or audio indications.

In some embodiments, a negative pressure wound therapy apparatus caninclude a negative pressure source, a pressure sensor, and a controller.The negative pressure source can include a plurality of inletsconfigured to be coupled via a plurality of fluid flow paths to aplurality of wound dressings and provide negative pressure to theplurality of wound dressings. The plurality of fluid flow paths caninclude a first fluid flow path configured to fluidically connect afirst wound dressing to a first inlet of the plurality of inlets and asecond fluid flow path configured to fluidically connect a second wounddressing to a second inlet of the plurality of inlets. The first fluidflow path can include a flow restrictor or a flow enlarger. a pressuresensor configured to measure pressure in at least one of the pluralityof fluid flow paths. The controller can be configured to operate thenegative pressure source and provide, based on pressure measured by thepressure sensor, indication of at least one operating conditionassociated with at least one of the first or second fluid flow paths.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. The at least one operating condition caninclude one or more of a blockage, a leakage, an overpressure, or adressing full condition. The controller can be configured to provide theindication of the at least one operating condition based on pressurechanges over time. Pressure changes over time in the first fluid flowpath can be different from pressure changes over time in the secondfluid flow path. The controller can be further configured to detect ablockage in the first or second fluid flow path based on the differencein the pressure changes over time in the first and second fluid flowpaths. The apparatus can further include a housing configured to supportthe negative pressure source and the first and second inlets. The firstfluid flow path can include a first identifier configured to indicate toa user a fluidic connection between the first wound dressing and thenegative pressure source. The second fluid flow path can include asecond identifier configured to indicate to the user a fluidicconnection between the second wound dressing and the negative pressuresource. The first and second identifiers can include at least one of aprinted glyph, a printed icon, an embossed glyph, an embossed icon, abraille character, or a color coding. The controller can be furtherconfigured to provide a first indication associated with an operatingcondition in the first fluid flow path and a second indicationassociated with an operating condition in the second fluid flow path.The first and second indications can be one or more of visual or audioindications.

In some embodiments, a negative pressure therapy apparatus can include anegative pressure source, a pressure sensor and a controller. Thenegative pressure source can be configured to couple via a plurality offluid flow paths to a plurality of wound dressings and provide negativepressure to the plurality of wound dressings. The plurality of fluidflow paths can include a first fluid flow path and a second fluid flowpath. The first fluid flow path can be configured to fluidically connecta first wound dressing to the negative pressure source The first fluidflow path can have a first valve configured to block passage of fluid inthe first fluid flow path. The second fluid flow path can be configuredto fluidically connect a second wound dressing to the negative pressuresource. The second fluid flow path can have a second valve configured toblock passage of fluid in the second fluid flow path. The pressuresensor can be configured to measure pressure in the plurality of fluidflow paths. The controller can be configured to operate the negativepressure source and to detect an operating condition associated with atleast one of the first or second fluid paths based on the measuredpressure.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. The controller can be configured to detect anoperating condition in the first fluid flow path when the first valve isopen to allow passage of fluid in the first fluid flow path and thesecond valve is closed to block passage of fluid in the second fluidflow path. The operating condition in the first fluid flow path caninclude blockage in the first fluid flow path. The plurality of fluidflow paths further can include a third fluid flow path configured tofluidically connect a third wound dressing to the negative pressuresource. The third fluid flow path can include a third valve configuredto block passage of fluid in the third fluid flow path. The controllercan be configured to detect an operating condition in the first fluidflow path when the first valve is open to allow passage of fluid in thefirst fluid flow path, the second valve is closed to block passage offluid in the second fluid flow path, and the third valve is closed toblock passage of fluid in the third fluid flow path.

The apparatus of any of the two preceding paragraphs may also includeany combination of the following features described in this paragraph,among others described herein. The controller can be further configuredto close the first valve to block passage of fluid in the first fluidflow path, close the second valve to block passage of fluid in thesecond fluid flow path, open the third valve to allow passage of fluidin the third fluid flow path, based on comparing the measured pressureto a first threshold, determine presence of a blockage in the thirdfluid flow path, and in response to determining that the blockage ispresent in the third fluid flow path, provide indication of the blockageto a user. The controller can be further configured to in response todetermining blockage in the third fluid flow path open the first valveto allow passage of fluid in the first fluid flow path, open the secondvalve to allow passage of fluid in the second fluid flow path, close thethird valve to block passage of fluid in the third fluid flow path,based on comparing the measured pressure to a second threshold,determine presence of a blockage in one or more of the first and secondfluid flow paths, and in response to determining that the blockage isnot present in the first and second fluid flow paths, provide indicationto replace the third wound dressing. The controller is furtherconfigured to, in response to determining that the blockage is presentin at least one of the first or second fluid flow paths, provideindication of the blockage to the user.

In some embodiments, a method of operating a negative pressure woundtherapy device includes closing a first valve associated with a firstfluid flow path. The first fluid flow path can be configured to providefluidic connection between a negative pressure source and a first wounddressing. Closing the first valve can block flow of fluid in the firstfluid flow path. The method can further include opening a second valveassociated with a second fluid flow path. The second fluid flow path canbe configured to provide fluidic connection between the negativepressure source and a second wound dressing. Opening the second valvecan allow flow of fluid in the second fluid flow path. The method canfurther include determining an operating condition associated with thesecond fluid flow path based at least in part on a measured pressure inthe second fluid flow path. The method can further include providingindication of the operating condition.

The method of the preceding paragraph may also include any combinationof the following features or steps described in this paragraph, amongothers described herein. The operating condition associated with thesecond fluid flow path can include blockage in the second fluid flowpath. The method can further include, in response to determiningblockage in the second fluid flow path, closing the second valve andopening the first valve; and providing an indication to replace thesecond dressing. The method can further include determining an operatingcondition associated with the first fluid flow path. The method canfurther include a third fluid flow path configured to provide fluidicconnection between the negative pressure source and a third wounddressing. The third fluid flow path can include a third valve configuredto provide fluidic connection between the negative pressure source andthe third wound dressing. Closing the third valve blocks flow of fluidin the third fluid flow path.

In some embodiments, a method of operating a negative pressure woundtherapy device includes opening a first valve associated with a firstfluid flow path. The first fluid flow path can be configured to providefluidic connection between a negative pressure source and a first wounddressing. Closing the first valve blocks fluid flow in the first fluidflow path. The method can further include closing a second valveassociated with a second fluid flow path. The second fluid flow path canbe configured to provide fluidic connection between the negativepressure source and a second wound dressing. Opening the second valveallows fluid flow in the second fluid flow path. The method can furtherinclude closing a third valve associated with a third fluid flow path.The third fluid flow path can be configured to provide fluidicconnection from a negative pressure source to a third wound dressing.Closing the third valve blocks fluid flow in the third fluid flow path.The method can further include determining presence of a blockage in thefirst fluid flow path based at least in part on a measured pressure inthe first fluid flow path. The method can further include upon adetermination of the blockage in the first fluid flow path, closing thefirst valve (e.g., closing the first valve blocks the flow of fluid inthe first fluid flow path), opening the second and third valves (e.g.,opening the second and third valves allows flow of fluid in the secondand third fluid flow paths), determining presence of a blockage in atleast one of the second or third fluid flow paths, in response todetermining that there is no blockage in the second and third fluid flowpaths, providing an indication to a user to replace the first wounddressing, and in response to determining that there is blockage in atleast one of the second or third fluid flow paths, provide indication tothe user.

In some embodiments, a negative pressure therapy apparatus can include awound dressing. The wound dressing can include a substantiallystretchable wound contact layer including a wound facing side and anon-wound facing side opposite the wound facing side. The wound facingside of the wound contact layer can be configured to be positioned incontact with a wound. The wound facing side of the wound contact layercan support a plurality of electronic components and a plurality ofelectronic connections that connect at least some of the plurality ofthe electronic components. The wound facing side of the wound contactlayer can include a first region of substantially non-stretchablematerial that supports at least one electronic component from theplurality of electronic components. The at least one electroniccomponent can be attached to the first region of substantiallynon-stretchable material with adhesive material.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. The wound facing side of the wound contactlayer can include a second region of substantially non-stretchablematerial that supports at least one electronic connection from theplurality of electronic connections. The wound contact layer can includea substrate supporting the plurality of electronic components and theplurality of electronic connections and a conformal coating covering atleast the plurality of electronic components and the plurality ofelectronic connections. The conformal coating can be configured toprevent fluid from coming into contact with the plurality of electroniccomponents and the plurality of electronic connections. The substratecan be formed from thermoplastic polyurethane and the conformal coatingis formed from urethane. The wound contact layer can include a pluralityof perforations configured to allow fluid to pass through the woundcontact layer when negative pressure is applied to the wound. Theplurality of perforations can be further configured to allowsubstantially unidirectional flow of fluid through the wound contactlayer to prevent fluid removed from the wound from flowing back towardthe wound.

The apparatus of any of the two preceding paragraphs may also includeany combination of the following features described in this paragraph,among others described herein. The wound facing side of the woundcontact layer can include a region of additional adhesive materialconfigured to position the at least one electronic component in thewound. The wound facing side of the wound contact layer can include athird region of substantially non-stretchable material that encloses theat least one electronic component. The at least one electronic componentcan include one or more of a sensor, a light emitter, a processor, or acommunications controller. The plurality of electronic connections caninclude a plurality of electrical traces. The apparatus can furtherinclude a negative pressure source configured to be fluidicallyconnected to the wound dressing. The wound dressing can further includean absorbent layer positioned over the non-wound facing side of thewound contact layer and a backing layer positioned over the absorbentlayer. The wound contact layer can be sealed to the backing layer. Theapparatus can further include a port on the backing layer. The port canbe configured to fluidically connect the wound dressing to a negativepressure source. The adhesive material can be thermally curable.

The apparatus of any of the preceding paragraphs may also include anycombination of the following features described in this paragraph, amongothers described herein. The apparatus can further include an indicatorconfigured to alert a user to check at least one of the plurality ofwound dressings; a processor configured to periodically activate theindicator; and a button configured permit the user to reset the alertfor the user to check at least one of the plurality of wound dressings.

In some embodiments, a method of manufacturing a wound dressing includesproviding a substantially stretchable wound contact layer including awound facing side and a non-wound facing side opposite the wound facingside. The wound facing side of the wound contact layer can be configuredto be positioned in contact with a wound. The method can further includepositioning a first region of substantially non-stretchable material onthe wound facing side of the wound contact layer and positioning aplurality of electronic components and a plurality of electronicconnections on the wound facing side of the wound contact layer. The atleast one electronic component from the plurality of electroniccomponents can be supported by the first region of substantiallynon-stretchable material, and at least one electronic component can beattached to the first region of substantially non-stretchable materialwith adhesive material.

The method of the preceding paragraph may also include any combinationof the following features or steps described in this paragraph, amongothers described herein. The wound contact layer can include asubstrate. The method can further include perforating the substratearound the plurality of electronic components and the plurality ofelectronic connections; and applying conformal coating over at least theplurality of electronic components and the plurality of electronicconnections. The conformal coating can be configured to prevent fluidfrom coming into contact with the plurality of electronic components andthe plurality of electronic connections. The method can further includeidentifying a plurality of locations of the plurality of electroniccomponents and the plurality of electronic connections on the substrateprior to perforating the substrate around the plurality of electroniccomponents and the plurality of electronic connections. Identifying theplurality of locations can include identifying one or more of: alocation of an RFID chip or antenna positioned on the substrate or alocation of an electronic connection configured to be connected to anelectronic component external to the substrate.

The method of any of the two preceding paragraphs may also include anycombination of the following features or steps described in thisparagraph, among others described herein. The method can further includeapplying a region of additional adhesive material to the wound facingside of the wound contact layer. The additional adhesive material can beconfigured to position the at least one electronic component in thewound. The method can further include identifying a location of the atleast one electronic component prior to applying the region ofadditional adhesive material. The wound contact layer can include asubstrate. The method can further include applying conformal coatingover at least the plurality of electronic components and the pluralityof electronic connections. The conformal coating can be configured toprevent fluid from coming into contact with the plurality of electroniccomponents and the plurality of electronic connections. The method canfurther include applying a region of adhesive material to the woundfacing side of the wound contact layer, the adhesive material configuredto position the at least one electronic component in the wound; andperforating the substrate around the plurality of electronic componentsand the plurality of electronic connections. The method can furtherinclude identifying a plurality of locations of the plurality ofelectronic components and the plurality of electronic connections on thesubstrate prior to perforating the substrate around the plurality ofelectronic components and the plurality of electronic connections.

The method of any of the three preceding paragraphs may also include anycombination of the following features or steps described in thisparagraph, among others described herein. The method can further includeidentifying a location of the at least one electronic component prior toapplying the region of adhesive material. Identifying the plurality oflocations can include identifying one or more of: a location of an RFIDchip or antenna positioned on the substrate or a location of anelectronic connection configured to be connected to an electroniccomponent external to the substrate. The method can further includepositioning a second region of substantially non-stretchable material onthe wound facing side of the wound contact layer; and supporting atleast one electronic connection from the plurality of electronicconnections on the second region. The method can further includeenclosing the at least one electronic component by a third region ofsubstantially non-stretchable material positioned on the wound facingside of the wound contact layer. The method can further include cuttingthe wound contact layer along at least one cutting line to separate aregion of the wound contact layer including the plurality of electroniccomponents and the plurality of electronic connections; and attachingthe region of the wound contact layer to one or more of an absorbentlayer or a backing layer to form a wound dressing. The substrate can beformed thermoplastic polyurethane and the conformal coating is formedfrom urethane. The adhesive material can be thermally curable.

Any of the features, components, or details of any of the arrangementsor embodiments disclosed in this application, including withoutlimitation any of the pump embodiments and any of the negative pressurewound therapy embodiments disclosed below, are interchangeablycombinable with any other features, components, or details of any of thearrangements or embodiments disclosed herein to form new arrangementsand embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a negative pressure therapy system that includes aTNP apparatus and a remote data processing system according to someembodiments.

FIG. 2 illustrates a negative pressure therapy system that includes theTNP apparatus of FIG. 1, as well as an inlet manifold branchingattachment, pressure sensor and a plurality of fluid flow paths, wounddressings positioned over wounds according to some embodiments.

FIG. 3 illustrates some embodiments of negative pressure therapy system200 of FIG. 2.

FIGS. 4A-C illustrate the inlet manifold branching attachment of FIG. 3according to some embodiments.

FIG. 5 illustrates a diagram of a negative pressure wound treatmentsystem according to some embodiments.

FIG. 6 illustrates a diagram of a negative pressure wound treatmentsystem according to some embodiments.

FIG. 7 illustrates a diagram of a negative pressure wound treatmentsystem according to some embodiments.

FIGS. 8A-8B illustrates diagrams of a TNP apparatus according to someembodiments.

FIG. 9 illustrates a diagnostics process performed by a negativepressure wound treatment system according to some embodiments.

FIG. 10 illustrates a diagnostics process performed by a negativepressure wound treatment system according to some embodiments.

FIG. 11 illustrates a diagnostics process performed by a negativepressure wound treatment system according to some embodiments.

FIGS. 12A-12C illustrate portable negative pressure apparatusesaccording to some embodiments.

FIGS. 12D-12G illustrate user interfaces for a portable negativepressure apparatus according to some embodiments.

FIG. 13 illustrates a wound dressing according to some embodiments.

FIG. 14 illustrates a cross section of an embodiment of a fluidicconnector connected to a wound dressing.

FIGS. 15A-15D illustrate embodiments of a wound dressing incorporatingnegative pressure indicators according to some embodiments.

DETAILED DESCRIPTION

Embodiments disclosed herein relate to apparatuses and methods oftreating a plurality of wounds with reduced pressure, including a sourceof negative pressure and wound dressing components and apparatuses. Theapparatuses and components including a wound overlay and packingmaterials, if any, may collectively be referred to as dressings.

Embodiments disclosed herein relate to wound therapy for a human oranimal body. Therefore, any reference to a wound herein can refer to awound on a human or animal body, and any reference to a body herein canrefer to a human or animal body. The term “wound” as used herein, inaddition to having its broad ordinary meaning, includes any body part ofa patient that may be treated using negative pressure. It is to beunderstood that the term wound is to be broadly construed andencompasses open and closed wounds in which skin is torn, cut orpunctured or where trauma causes a contusion, or any other superficialor other conditions or imperfections on the skin of a patient orotherwise that benefit from reduced pressure treatment. A wound is thusbroadly defined as any damaged region of tissue where fluid may or maynot be produced. Examples of such wounds include, but are not limitedto, abdominal wounds or other large or incisional wounds, either as aresult of surgery, trauma, sterniotomies, fasciotomies, or otherconditions, dehisced wounds, acute wounds, chronic wounds, subacute anddehisced wounds, traumatic wounds, flaps and skin grafts, lacerations,abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stoma,surgical wounds, trauma and venous ulcers or the like.

Treatment of such wounds can be performed using negative pressure woundtherapy, wherein a reduced or negative pressure can be applied to thewound to facilitate and promote healing of the wound. It will also beappreciated that the wound dressing and methods as disclosed herein maybe applied to other parts of the body, and are not necessarily limitedto treatment of wounds.

It will be understood that embodiments of the present disclosure aregenerally applicable to use in topical negative pressure (TNP) therapysystems. Briefly, negative pressure wound therapy assists in the closureand healing of many forms of “hard to heal” wounds by reducing tissueoedema; encouraging blood flow and granular tissue formation; removingexcess exudate and may reduce bacterial load (and thus infection risk).In addition, the therapy allows for less disturbance of a wound leadingto more rapid healing. TNP therapy systems may also assist on thehealing of surgically closed wounds by removing fluid and by helping tostabilize the tissue in the apposed position of closure. A furtherbeneficial use of TNP therapy can be found in grafts and flaps whereremoval of excess fluid is important and close proximity of the graft totissue is required in order to ensure tissue viability.

As is used herein, reduced or negative pressure levels, such as −X mmHg,represent pressure levels relative to normal ambient atmosphericpressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg,101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure valueof, for example, −X mmHg reflects pressure that is X mmHg below 760 mmHgor, in other words, a pressure of (760-X) mmHg. In addition, negativepressure that is “less” or “smaller” than X mmHg may correspond topressure that is closer to atmospheric pressure (such as, −40 mmHg isless than −60 mmHg). Negative pressure that is “more” or “greater” than−X mmHg may correspond to pressure that is further from atmosphericpressure (such as, −80 mmHg is more than −60 mmHg). In some embodiments,local ambient atmospheric pressure is used as a reference point, andsuch local atmospheric pressure may not necessarily be, for example, 760mmHg.

The negative pressure range for some embodiments of the presentdisclosure can be approximately −80 mmHg, or between about −20 mmHg and−200 mmHg Note that these pressures are relative to normal ambientatmospheric pressure, which can be 760 mmHg Thus, −200 mmHg would beabout 560 mmHg in practical terms. In some embodiments, the pressurerange can be between about −40 mmHg and −150 mmHg. Alternatively, apressure range of up to −75 mmHg, up to −80 mmHg or over −80 mmHg can beused. Also in other embodiments, a pressure range of below −75 mmHg canbe used. Alternatively, the negative pressure apparatus can supply apressure range of over approximately −100 mmHg, or even −150 mmHg.

In some embodiments of wound closure devices described herein, increasedwound contraction can lead to increased tissue expansion in thesurrounding wound tissue. This effect may be increased by varying theforce applied to the tissue, for example by varying the negativepressure applied to the wound over time, possibly in conjunction withincreased tensile forces applied to the wound via embodiments of thewound closure devices. In some embodiments, negative pressure may bevaried over time for example using a sinusoidal wave, square wave,and/or in synchronization with one or more patient physiological indices(such as, heartbeat).

FIG. 1 illustrates a negative pressure therapy system 100 that includesa TNP apparatus 102 and a remote data processing system 122 according tosome embodiments. The TNP apparatus 102 can be used to treat a woundusing a wound dressing that is in fluidic communication with the TNPapparatus 102 via a fluid flow path. The TNP apparatus 102 can include acontroller 104, a memory device 106, a negative pressure source 108, auser interface 110, a power source 112, a pressure sensor 114, and atransceiver 116 that are configured to electrically communicate with oneanother. The power source 112 can provide power to one or morecomponents of the TNP apparatus 102.

The controller 104 can control operations of one or more othercomponents of the TNP apparatus 102 according at least to instructionsstored in the memory device 106. The controller 104 can, for instance,control operations of and supply of negative pressure by the negativepressure source 108. The negative pressure source 108 can include apump, such as, without limitation, a rotary diaphragm pump or otherdiaphragm pump, a piezoelectric pump, a peristaltic pump, a piston pump,a rotary vane pump, a liquid ring pump, a scroll pump, a diaphragm pumpoperated by a piezoelectric transducer, a pump operated by a voice coilactuator, or any other suitable pump or micropump or any combinations ofthe foregoing. The user interface 110 can include one or more elementsthat receive user inputs or provide user outputs to a patient orcaregiver. The one or more elements that receive user inputs can includebuttons, switches, dials, touch screens, or the like.

The pressure sensor 114 can be used to monitor pressure underneath awound dressing, such as (i) pressure in a fluid flow path connecting theTNP apparatus 102 and the wound dressing, (ii) pressure at the wounddressing, or (iii) pressure at or in the TNP apparatus 102. In someimplementations, the pressure sensor 114 can include at least two ormore pressure sensors that are positioned to measure the pressure ofmultiple fluid flow paths, such as multiple flow paths connecting theTNP apparatus 102 to multiple wound dressings. On other implementations,the pressure sensor 114 can include at least two or more pressuresensors that are positioned in or fluidically connected to the fluidflow path to permit differential measurement of the pressure. Forexample, a first pressure sensor can be positioned upstream of the wound(such as at or near the inlet of the TNP apparatus 102) and a secondpressure sensor can be positioned to detect pressure at or near thewound or at or near a canister or dressing.

The transceiver 116 can be used to communicate with the data processingsystem 122 via a network 120. The transceiver 116 can, for example,transmit device usage data like alarms, measured pressure, or changes toa therapy program administered by the TNP apparatus 102 to the dataprocessing system 122. In some examples, the transceiver 116 communicatewith one or more shut-off valves in a negative pressure therapy system.The network 120 can be a communication network, such as a wired orwireless communications network (for example, a cellular communicationsnetwork). The memory device 106 can be used to store the device usagedata that may be transmitted by the transceiver 116. In someembodiments, the data processing system 122 can transmit data, such asoperating parameters, to the TNP apparatus 102.

FIG. 2 illustrates a negative pressure therapy system 200 according tosome embodiments. The system 200 includes the TNP apparatus 102 of FIG.1, as well as a first fluid flow path 208, a first wound dressing 202configured to be placed over a first wound 220, a second fluid flow path210, a second wound dressing 204 configured to be placed over a secondwound 222, an inlet manifold branching attachment 206, and a third fluidflow path 212. The TNP apparatus 102 can be used to treat the firstwound 220 using the first wound dressing 202 that is in fluidiccommunication with the TNP apparatus 102 via the first fluid flow path208, the inlet manifold branching attachment 206, and the third fluidflow path 212. The TNP apparatus 102 can also be used to treat thesecond wound 222 using the second wound dressing 204 that is in fluidiccommunication with the TNP apparatus 102 via the second fluid flow path210, the inlet manifold branching attachment 206, and the third fluidflow path 212.

The inlet manifold branching attachment 206 is attached between the TNPapparatus 102 and the first and second wound dressings, therebyadvantageously enabling the TNP apparatus 102 to generate and maintainnegative pressure in or under both of the wound dressingssimultaneously. In this example, the inlet manifolds are notincorporated into the TNP apparatus. Instead, an inlet manifoldbranching attachment 206, such as a Y-shaped connector, is used toconnect the first and second fluid flow paths 208-B to the third fluidflow path 212. In other examples, inlet manifolds can be incorporatedinto the TNP apparatus 102 (as shown in FIGS. 12A-12C) such that thefirst and second fluid flow paths connect directly to the TNP apparatusvia integrated inlet manifolds.

A pressure sensor 114 is positioned in the third fluid flow path 212,such as at or near an inlet of the TNP apparatus 102, to measurepressure in the third fluid flow path 212. The controller of the TNPapparatus 102 can monitor the pressure measured by the pressure sensor114 and determine whether an operating condition (for example, ablockage, leakage, overpressure, or dressing full condition) hasoccurred in within the negative pressure therapy system 200.

In some instances, the controller can determine that an operatingcondition exists by comparing the measured pressure to an expectedmeasured pressure (or flow). An “expected” pressure (or flow) can be thepressure measured by a pressure sensor in a negative pressure systemoperating in a normal state. The expected pressure can be equivalent oralmost equivalent (for example, within 1, 2, 3, 4, 5, 10, 15, or 20mmHg) to a pressure supplied by the negative pressure source (or apressure selected by a user). In contrast, an “unexpected” pressure (orflow) can be any measured pressure other than the expected pressure (orflow). For instance, in some examples, a wound dressing experiencing ablockage, overpressure, or dressing full condition, can cause thepressure sensor to measure a lower (for example, more positive pressure)than expected pressure. In other examples, a wound dressing experiencinga leakage condition can cause the pressure sensor to measure a lowerthan expected pressure. In some examples, an operating condition canchange the measured pressure (for example, spike, dip, increase, ordecrease in measured pressure). In some embodiments, measured pressureis compared to one or more thresholds in order to determine if it isexpected or unexpected.

In some examples, the TNP apparatus 102 will only function (for example,provide negative pressure) when two or more wound dressings areconnected. Additionally, some indicators or functionality of the TNPapparatus that is available when only a single wound dressing isconnected may be disabled so as not to confuse the user. For example, insome instances the dressing full indicator is not available for TNPsystems having more than one connected wound dressing. Thus, thedressing full indicator(s) can be disabled or removed from the frontpanel so as not to confuse the user with unavailable functionality.

FIG. 3 illustrates some embodiments of negative pressure therapy system200. The system 200 includes a TNP apparatus 102, a first fluid flowpath 208, a first wound dressing 202, a second fluid flow path 210, asecond wound dressing 204, a plurality of integrated inlet manifolds orconnectors 302, 304. The plurality of integrated inlet manifolds 302,304 are integrated with the TNP apparatus 102 and are fluidicallyconnected to the first wound dressing 202 via the first fluid flow path208 and the second wound dressing 204 via the second fluid flow path210.

In some instances, a fluid flow path 208 can be lengthy and in alocation remote from the TNP apparatus 102. As such, it can be desirablefor the fluid flow paths to include one or more indicators 306, 308which would be helpful to a user in identifying which fluid flow path208 is connected to a particular inlet of the plurality of integratedinlet manifolds 306, 308.

As shown, the first fluid flow path 208 includes a plurality of firstidentifiers (stars) 306, and the second fluid flow path 208 includes aplurality of second identifiers (triangles) 308. In both instances, atleast one identifier 306, 308 is located in close proximity to the inletmanifolds 306, 308 and at least one identifier is located in closeproximity to a wound dressing. In some examples, a fluid flow path caninclude more than two identifiers 306, 308. For example, identifiers306, 308 can be located across the length of the fluid flow path.Moreover, an identifier 306, 308 can alternatively include a printedglyph, a printed icon, an embossed glyph, an embossed icon, a braillecharacter, a color-coding and the like. In some examples, anelectronically controlled indication (such as an LED, an indicator on adisplay, etc.) is associated with each fluid flow path. This facilitatesthe TNP apparatus 102 in indicating an operating condition that may haveoccurred on the associated dressing.

In some embodiments, at least one pressure sensor can be positioned withan inlet manifold (either an integrated manifold or attachment manifold)to measure the combined pressure of the first and second fluid flowpaths. The controller of the TNP apparatus 102 monitors the pressuremeasured by the pressure sensor and determines whether an operatingcondition has occurred in any of the fluid flow paths. In some aspects,the controller can be configured to provide a first indicationassociated with an operating condition in the first fluid flow path 208and a second indication associated with an operating condition in thesecond fluid flow path 210.

In some examples, a negative pressure therapy system includes more thantwo wound dressings. Accordingly, the number of fluids flow paths andinlets can correspond with the number of wound dressings. For instance,a negative pressure therapy system having four wound dressings can haveat least four fluid flow paths and at least four inlets manifolds. Insome examples, a single wound dressing can be configured to communicatewith a TNP apparatus via more than one fluid flow path. In someexamples, the negative pressure therapy system can include more inletsmanifolds than fluid flow paths and/or wound dressings. In examples suchas these, the additional inlets can be disregarded or plugged.

FIGS. 4A-4C illustrate an inlet manifold branching attachment 206according to some embodiments. In some examples, the inlet manifoldbranching attachment 206 can be used in place of the integrated inletmanifold of FIG. 3. As illustrated, the Y-shaped inlet manifoldbranching attachment 206 can include three conduit attachment portions306, 308, 410. A pump conduit attachment portion 410 can be used toconnect to a conduit or tubing extending from a pump or TNP apparatus orto connect to the pump itself. The pump conduit attachment portion 410can include a male non-luer connector at a proximal end of the Y-shapedinlet manifold branching attachment. The male connector can attach to afemale connector of a conduit or pump. The pump conduit attachmentportion 410 has a shaft 408 extending from the attachment portion andforming the bottom portion of the Y shape of the inlet manifoldbranching attachment 206.

The Y-shaped inlet manifold branching attachment also includes twodressing conduit attachment portions 306, 308. The dressing conduitattachment portions 306, 308 can be used to connect to the coupling ofthe fluid flow path extending from a wound dressing. In someembodiments, a conduit or tubing can be used to connect the inletmanifold branching attachment to the Y-shaped inlet manifold branchingattachment 206. The conduit or tubing may be a soft bridge, a hard tube,or any other apparatus that may serve to transport fluid. The conduit ortubing can include a coupling at a proximal end and at a distal end. Theconduit or tubing can be connected to the coupling of the inlet manifoldbranching attachment at the distal end and connected to the conduitattachment portions of the Y-shaped inlet manifold branching attachmentat the proximal end of the conduit.

The dressing conduit attachment portion 306, 308 can include a femalenon-luer connector at a distal end of the Y-shaped inlet manifoldbranching attachment. The female connector can attach to a maleconnector of the coupling of the inlet manifold branching attachment orto the coupling of the conduit.

In some embodiments, the inlet manifold branching attachment 206 or theconduit can include incorporated valve(s), clamp(s), cap(s), and/orother closure mechanisms. Accordingly, flow or passage of fluid to andfrom one wound dressing can be blocked while another wound dressingcontinues to apply negative pressure. In some embodiments, the closuremechanism can be a valve, for example, a non-return valve.

In some examples, the valves incorporated in the Y-shaped inlet manifoldbranching attachment 206 are manual shut-off valves. For instance, auser can manually close a valve associated with conduit attachmentportion 306 thereby blocking the fluid flow to and from the first wounddressing 202. Similarly, a user can manually close a valve associatedwith conduit attachment portion 308 thereby blocking the fluid flow toand from the second wound dressing 204. In some examples, a valve existsin conduit attachment potion 410, wherein closure of said valve wouldblock fluid flow to and from the first and second wound dressings 202,204.

In some examples, the valves incorporated in the Y-shaped inlet manifoldbranching attachment 206 are electromechanical valves. For instance, acontroller (for example, the controller of the TNP apparatus asdescribed in FIG. 1) can communicate with the valves to open and/orclose each valve individually or as a unit. The communication betweenthe valves and the TNP apparatus 102 can be wired or wireless. Forinstance, a wireless transceiver (e.g., see FIG. 1) of TNP apparatus 102can communicate with a wireless transceiver of the valves. The wirelesstransceiver of the valves can be positioned within the inlet manifoldbranching attachment 206 or within close proximity to the inlet manifoldbranching attachment 206.

The dressing conduit attachment portions 306, 308 include shafts 404,402, respectively, forming the top portions of the Y shape of theconnector. The proximal ends of shafts 404, 402 and the distal end ofshaft 408 meet at a joint 406. In some embodiments, the joint 406 caninclude a hinge that allows rotation of the shafts 404, 402, 408 aboutthe joint 406. In some embodiments, only shafts 404, 402 of the dressingconduit attachment portions can move relative to the joint 406 and theshaft 408 of the pump conduit attachment portion is fixed. In someembodiments, the whole Y-shaped inlet manifold branching attachment willbe in two parts that allow 360° rotation. FIG. 4C illustrates anembodiment of the Y-shaped inlet manifold branching attachment that isformed of two freely rotating parts that allow rotation of each partrelative to the other. The rotation of the Y-shaped inlet manifoldbranching attachment can allow the user to twist the pump around whilethe wound dressings and conduits extending from the wound dressingsremain stationary.

In some embodiments, the male and female non-luer connectors can be arigid plastic. In some embodiments, the shafts 408, 404, 402 can be aflexible plastic tubing. In some embodiments, the Y-shaped inletmanifold branching attachment can be encased in a soft silicone sleeveto increase patient comfort and prevent the Y-shaped inlet manifoldbranching attachment from becoming a pressure point.

Utilizing the Y-shaped inlet manifold branching attachment 206illustrated in FIGS. 4A-4C to attach a single pump to the two wounddressings, the TNP apparatus 102 can draw pressure in the two wounddressings simultaneously. The performance and fluid management of themultisite dressing and Y-connector is equivalent to a control test ofthe standard single wound dressing with single pump set-up. Although theattachment 206 is illustrated as being Y-shaped, the attachment 206 canbe of any suitable shape or combination of shapes in someimplementations. In some embodiments, luer, quick release, or othertypes of connectors can be used as one or more connectors of theattachment 206, the TNP apparatus 102, and one or more of the fluid flowpaths 208, 210.

In some examples, a negative pressure therapy system can include morethan two wound dressings and associated fluid flow paths in fluidiccommunication with the inlet manifold branching attachment. As such, insome embodiments, the inlet manifold branching attachment is attached tomore than one TNP apparatus and/or more than two fluid flow paths (suchas, one pressure source and three wound dressings (“1:3”), 1:4, 1:5,2:1, 2:2, 2:3, 2:4, 2:5). The inlet manifold branching attachment can bea separate attachment, such as the Y-shaped connector that can connectto the third fluid flow path, or inlet manifolds can be incorporatedinto the TNP apparatus 102. The total number of inlet manifolds (forexample, the number of “splits” performed by the inlet manifoldbranching attachment) that the inlet manifold branching attachmentcontains can be the same as the number of dressings to be connected. Insome instances, one or more inlet manifolds connect to a single wounddressing.

FIG. 5 illustrates a negative pressure therapy system 500 havingpressure sensors 502, 504, 506 positioned to measure each fluid flowpath associated with wound dressings. In particular, a first pressuresensor 502 measure pressures in a first fluid flow path 208; a secondpressure sensor 504 measured the pressure in a second fluid flow path210; and a third pressure sensor 506 measures the pressure in a thirdfluid flow path 212.

By positioning a sensor within each of the fluid flow paths, thecontroller can monitor the pressure of each fluid flow path to determinewhether an operating condition has occurred in the negative pressuretherapy system 500. Additionally, because a sensor measures pressure oneach of the fluid flow paths, upon determination of an operatingcondition, the controller can specifically determine which flowpath/wound dressing combination is experiencing an operating condition.The negative pressure therapy system 500 provides the capability tomonitor the functionality of individual wound dressings, therebyenabling the same set of features and functionality offered by anegative pressure therapy system utilizing a single wound dressing.

The pressure sensors 502, 504, 506 can be positioned anywhere in thefluid flow paths, such as between the wound dressings and the inletmanifold branching attachment 206 or at or near a wound dressing. Insome examples, to reduce costs, the number of pressure sensors is onefewer than the number of wound dressings. For instance, where the numberof wound dressings is N, only N−1 pressure sensors are employed in thenegative pressure therapy system. In examples such as these, acontroller can perform a process to determine whether the dressingwithout an associated pressure sensor is experiencing an operatingcondition. In some examples, as described above with respect to FIGS.4A-C, one or more pressure sensors into an inlet manifold branchingattachment 206.

A plurality of shut-off valves 512, 514, 516 (for example, asillustrated in FIG. 12C) can be positioned in the negative pressuretherapy system 500 such that the closure of a valve blocks passage offluid to and from an associated wound dressing. The shut-off valves 512,514, 516 can be positioned anywhere in the fluid flow path, such asbetween the inlet manifold branching attachment 206 outlet and acorresponding dressing inlet. In some examples, as described above withrespect to FIGS. 4A-C, one or more shut-off valves are integrated intoan inlet manifold branching attachment 206.

In some examples, the valves 512, 514, 516 are manual shut-off valves.For instance, a user can manually close the first valve 512 therebyblocking the fluid flow to and from the first wound dressing 202. Inother examples, the valves are electromechanical valves. For instance,the TNP apparatus 102 can communicate with the valves to open and/orclose each valve individually or as a unit. The communication betweenthe valves and the TNP apparatus 102 can be wired or wireless. Forinstance, a wireless transceiver (see e.g., FIG. 1) of TNP apparatus 102can communicate with a wireless transceiver of the valves. In somecases, the wireless transceiver of the valves can be positioned withinthe inlet manifold branching attachment 206 or within close proximity tothe inlet manifold branching attachment.

In TNP system 500, the controller can efficiently determine which fluidflow path/wound dressing combination is experiencing an operatingcondition and, in some embodiments, can close an associated valve toimprove overall efficiency of the TNP apparatus. For instance, duringnormal operation in which no wound dressings are experiencing anoperating condition, the pressure sensors 502, 504, 506 may measureapproximately the same pressure. When a fluid flow path/wound dressingexperiences an operating condition, the measured pressure associatedwith that fluid flow path/wound dressing changes such that a controllercan determine: (1) which particular fluid flow path/wound dressing isexperiencing the operating condition and/or (2) which particular type ofoperating condition is being experienced. For example, if pressure ismeasured downstream of a blockage that occurs in the first fluid flowpath/wound dressing, the measured pressure in the first fluid flow pathcan increase (for example, become more negative) because the blockagerestricts the fluid flow and consequently decreases the volume in whichfluid flows. As another example, if pressure is measure upstream of theblockage in the first fluid flow path/wound dressing, the measuredpressure in the first fluid flow path can decrease (for example, becomemore positive) because the blockage severely restricts or blocks fluidflow in part of the fluid flow path where pressure is measured. Due tothis pressure change, the controller can determine that an operatingcondition (blockage) has occurred on the first fluid flow path/wounddressing. In some examples, operating conditions cause spike or spikesin measured pressure. In other examples, operating conditions cause anincrease or decrease in measured pressure. The controller can make thesedeterminations for blockage, overpressure, pressure leak, dressing fullconditions, and the like.

In some examples, electronically controllable valves are utilized toshut-off therapy to specific dressings to prevent loss of pressure andimprove overall efficiency of the TNP apparatus. This can be effectivein a negative pressure therapy system having a large number of wounddressings.

FIG. 6 illustrates a negative pressure therapy system 600 according tosome embodiments. The illustrated system differs from the negativepressure therapy system 200 in that it includes a flow reducer orrestrictor 602 in the first fluid flow path 208 and a plurality ofintegrated inlet manifolds 602, 604 have replaced the inlet manifoldbranching attachment 206. In some implementations, the inlet manifolds602, 604 can be replaced with a single inlet and a branching attachment206 and the flow restrictor 602 can be integrated into one of thepassageways or branches of the attachment 206. The addition of the flowrestrictor 602 allows the controller to determine which wound dressingis experiencing an operating condition despite utilizing a singlepressure sensor 114.

The flow restrictor 602 (such as a small volume receptacle or a smallorifice) limits the flow through the first fluid flow 208 path such thatthe difference in flow between the first fluid flow path 208 and thesecond fluid flow path 210 can be perceived by the controller. Forexample, the TNP apparatus 102 can draw pressure in the two wounddressings simultaneously. The flow restrictor 602 restricts the pressurein the first fluid flow path 208. In some embodiments, during normaloperation, flow detected by the system 600 (for example, a controller)will be the combination of flow through fluid flow paths 208 and 210,each of which may be known a priori (such as, calculated based oncharacteristics of each fluid flow paths, calculated via calibration,and the like). Upon the occurrence of an operating condition, such asblockage, in the first fluid flow path 208, detected flow will reduce toequal or nearly equal the flow through the flow path 210. Thus, thesystem 600 would not only detect change in flow, but would detect basedon the measured flow that fluid is flowing through fluid flow path 210and that fluid flow path 208 is experiencing a blockage. Similarly, thesystem 600 can detect and indicate an operating condition, such as ablockage, in fluid flow path 210. Indication of the operating conditioncan be performed using any of the approaches described herein, such asby audio-visual indication using an LED, display, and the like. Forexample, each of the fluid flow paths 208 and 210 may be associated witha particular color or symbol and such color or symbol can be displayedand/or announced. In some embodiments, measured flow is compared to oneor more thresholds.

In some embodiments, flow (or flow rate) can be monitored or measureddirectly by using a flow meter. In some implementations, flow can bemonitored or measured indirectly. For example, flow can be determined bymonitoring the change in pressure measured by the pressure sensor 114.The controller can determine the rate of flow, for example, bydetermining a pressure gradient, rate of change of pressure, or pressuredecay rate. As another example, in a system having a negative pressuresource that produces variable flow, flow rate can be determined based onpressure and speed of the negative pressure source (such as pump motor).For example, flow rate can be determined according to Equation 1 below:

Flow Rate=C ₁ *F*P+C ₂  (Equation 1)

where F is the pump speed (such as, frequency of a tachometer signalthat measures pump motor revolutions), P is measured pressure, and C₁and C₂ are suitable constants. Additional details are described U.S.Pat. No. 8,905,985 and U.S. Patent Publication No. 2012/0001762, each ofwhich is hereby incorporated by reference in its entirety.

In some embodiments, the flow restrictor 602 can be replaced with a flowenlarger configured to increase flow. In such cases, detection of anoperating condition will be similar to the foregoing with the exceptionthat the flow in the flow path 208 associated with the wound 220 isincreased by the flow restrictor.

In some embodiments, the flow restrictor 602 is a permanent restrictor,such as an orifice with a smaller diameter than one or more of theconduits in the fluid flow path 208. In some implementations, the flowrestrictor 602 is a temporary restrictor, such as an adjustable valve,that temporarily restricts the fluid flow when determination of whetheran operating condition is present is made. In some examples, thecontroller can control the temporary flow restrictor. In certainembodiments, a plurality of flow reducers and/or enhancers could beutilized in a system that includes more than two wound dressings andassociated fluid flow paths. For instance, a system with three wounddressings can include a flow restrictor in a first fluid flow path and aflow enhancer in a second fluid flow path. Similarly, a system withthree wound dressings can include a flow restrictor in a first fluidflow path and a stronger (or more narrow) flow restrictor in a secondfluid flow path. In any of these examples, the difference in flow ratesamong the plurality of fluid flow paths can permit the TNP apparatus todetermine which fluid flow path/wound dressing is experiencing anoperating condition.

In some examples, a canister can be coupled between the TNP apparatus102 and/or the plurality of integrated inlet manifolds 602, 604. Thecanister can collect exudate removed from the wounds 220, 222.Alternatively, a canister can be coupled between each wound dressing andthe inlet manifold branching attachment.

FIG. 7 illustrates a negative pressure therapy system 700 according tosome embodiments. System 700 differs from the negative pressure therapysystem 200 in that system 700 includes a third wound dressing 510, athird wound 518, a fourth fluid flow path 508, and a plurality ofshut-off valves 512, 514, 516. In addition to treating wounds 220-B asdescribed in 200, the system 700 can be utilized to treat the thirdwound 518 using the third wound dressing 510 that is in fluidiccommunication with the TNP apparatus 102 via the fourth fluid flow path508, the inlet manifold branching attachment 206, and the third fluidflow path 212.

The plurality of shut-off valves 512, 514, 516 are positioned in thefluid flow paths such that the closure of a corresponding valve blocksthe fluid flow to and from the connected fluid flow path/dressing. Theshut-off valve 21 can be positioned anywhere from the inlet manifoldbranching attachment 206 outlet to the corresponding dressing inlet. Asillustrated, a first valve 512 is positioned on the first fluid flowpath 208, a second valve 514 is positioned on the second fluid flow path210 and a third valve 516 is positioned on the fourth fluid flow path508.

In some examples, the plurality of valves 512, 514, 516 are manualshut-off valves. For instance, a user can manually close the first valve512 thereby blocking the fluid flow to and from the first wound dressing202. In other examples, each of the plurality of valves is anelectromechanical valve. For instance, the TNP apparatus can communicatewith the valves to open and/or close each valve individually or as aunit. The communication between the valves and the TNP apparatus 102 canbe wired or wireless. For instance, a wireless transceiver (see e.g.,FIG. 1) of TNP apparatus 102 can communicate with a wireless transceiverof the valves. The wireless transceiver of the valves can be positionedwithin the inlet manifold branching attachment 206 or within closeproximity to the inlet manifold branching attachment.

FIG. 8A illustrate a negative pressure therapy system 800A according tosome embodiments. In this example, the TNP apparatus 102 includes atleast a controller 104, a negative pressure source 108, a plurality ofpressure sensors 502, 504, and a plurality of integrated inlet manifolds306, 308.

The integrated inlet manifolds 602, 604 can be combined into a singleunit (e.g., as depicted in FIGS. 3 and 12), such that a single negativepressure passageway is connected to the negative pressure source 108.Alternatively, each of the plurality of integrated inlet manifolds 306,308 can directly connect to the negative pressure source without firstcombining with another inlet manifold.

The plurality of pressure sensors 502, 504 are positioned such that afirst pressure sensor 502 measures the pressure of the first fluid flowpath 208 connected to the first inlet manifold 306 and a second pressuresensor 504 measures the pressure of the second fluid flow path 210connected to the second inlet manifold 308. In some examples, thepressure sensors 502, 504 can be positioned within an inlet manifold. Inother examples, the pressure sensors are located with a housing of theTNP apparatus 102.

FIG. 8B illustrates a negative pressure therapy system 800B according tosome embodiments. In this example, the system 800B includes an inletmanifold branching attachment 206. As described herein, inlet manifoldscan include an inlet manifold branching attachment 206 (as illustratedin FIGS. 4A-4B) and/or can include one or more integrated inletmanifolds (as illustrated in FIGS. 12A-12C).

The inlet manifold branching attachment 206 includes a pressure sensor504 on a first branch 308 fluidically connected to the first dressing202 via the fluid flow path 208, as well as a wireless transceiver orreceiver 802 to communicate with the wireless receiver 804 incommunication with a controller 104 of the TNP apparatus 102. Thepressure sensor 504 measures pressure in the fluid flow path 208, whilepressure sensor 502 measures combined pressure in fluid flow paths 208and 210. Operating conditions, such as blockages, in one or more of thefluid flow paths 208 or 210 can be determined based on pressure measuredby the sensors 502 and 504 using any of the approaches described herein.In some examples, the inlet manifold branching attachment 206 cancommunicate with the TNP apparatus 102, for example, to provide pressuredata. The communication can be wired or wireless (for example, overBluetooth). In some examples, dressing-full detection and/or detectionof other operating conditions can be used to provide indication(s) tothe user.

FIG. 9 illustrates a diagnostics process 900 performed by a negativepressure wound treatment system 500 (see e.g., FIG. 5) according to someembodiments. Process 900 can be performed by a controller of thenegative pressure wound treatment system. As mentioned above, anoperating condition can include a blockage, leakage, overpressure,dressing full condition, or the like. The process can detect one of theforegoing operating conditions by analysing the pressure measured bypressure sensors 502, 504, 506.

At block 902, the process monitors the pressure sensors 502, 504, 506which measure pressure in various fluid flow paths 208, 210, and 508. Insome examples, the controller monitors the pressure sensors 502, 504,506 continuously, at predetermined intervals (such as, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, or60 minutes), and/or responsive to input by a user.

At block 904, the process determines that an operating condition hasoccurred based at least in part on a change in pressure measured by oneof the plurality of pressure sensors. For instance, an occurrence of ablockage in one of the wound dressings may cause a momentary orprolonged spike or dip in measured pressure. As another example, theprocess can determine flow based on measured pressure (or directly ifone or more flowmeters are utilized). As described with respect to FIG.5, by positioning a pressure sensor to monitor conditions in each of thefluid flow paths associated with the wound dressings, the process 900can monitor the pressure sensors 502, 504, 506 and determinespecifically which fluid flow path/wound dressing is experiencing anoperating condition. Thus, the negative pressure therapy system 500provides the capability to monitor the functionality of individual wounddressings, thereby enabling the same set of features offered by anegative pressure therapy system utilizing a single wound dressing.

At block 906, the process 900 provides indication of the flowpath/dressing (or flow paths/dressings) determined to be experiencing anoperating condition. In some examples, one or more LEDs or otherindicators can be used to indicate to a user or caregiver that anoperating condition has been detected. For example, each wound dressingcan have a corresponding LED that is ON when no operating condition isdetected on the associated wound dressing and OFF when an operatingcondition is detected on an associated wound dressing. In some examples,other indicators may be associated with wound dressing that isexperiencing an operating condition, such as sounds, wireless messages,display notifications and/or other signals that may get the attention ofa user or caregiver. In some examples, the TNP apparatus mayadditionally or alternatively provide indication by closing a valveassociated with the wound dressing experiencing the operating condition.

FIG. 10 illustrates a diagnostics process 1000 performed by a negativepressure wound treatment system 700 (see e.g., FIG. 7) according to someembodiments. Process 1000 can be performed by a controller of thenegative pressure wound treatment system. As mentioned above, anoperating condition can include a blockage, leakage, overpressure,dressing full condition, or the like. The process can detect one of theforegoing operating conditions by analysing the pressure measured bypressure sensor 502. When the process determines that an operatingcondition has occurred, it can initiate diagnostics to determine whichflow path/dressing is experiencing an operating condition. In someexamples, the process is implemented in firmware or software thatincorporates a diagnostic mode to determine which flow path/wounddressing is experiencing an operating condition. In some examples, anoperator can toggle between the operational modes through an interfaceof the TNP apparatus (such as, a touchscreen interface or dedicatedbuttons or switches).

At block 1002, the process 1000 monitors the pressure sensor 502, whichmeasures pressure at or in the TNP apparatus 102. In some examples, theprocess 1000 continuously monitors the pressure sensor 502. In otherexamples, the process 1000 monitors the pressure sensor 502 atpredetermined intervals (such as, 1 minute, 2 minutes, 5 minutes, 10minutes, 15 minutes, 20 minutes, 30 minutes, or 60 minutes). In otherexamples, the process can monitor the pressure sensor responsive toinput by a user.

At block 1004, the process determines that an operating condition has(or may have) occurred and initiates a diagnostic mode to determinewhich fluid flow path(s)/wound dressing(s) are experiencing an operatingcondition. During the diagnostic mode, the process can determine that anoperating condition has occurred based at least in part on a change inpressure measured by the pressure sensor 502, change in flow, and thelike. For instance, an occurrence of an operating condition on one ofthe fluid flow paths/wound dressings may cause a momentary or prolongedspike or dip in pressure measured by the pressure sensor 502.

In block 1006, a fluid flow path/wound dressing is selected for testing.In some examples, the user and/or the process can make this selection.For instance, the user can make the selection by providing input to theprocess. The section can be arbitrary, one based on the user'ssuspicions, or one based on the process's suggestion. In some examples,the process can make the selection. The process's selection, forinstance, can be random, based on user input, or based on data withinthe controller.

The valve associated with the selected fluid flow path/dressing isopened and the valve(s) associated with the unselected dressing(s) areclosed, thereby likening the negative therapy system to a negativepressure system having a single wound dressing fluidically connected toa negative pressure source. The valve(s) can be opened or closedmanually by a user or by the controller. In some examples, thecontroller can electronically (such as, through a wired or wirelessconnection) control the shut-off valves. For instance, a wirelesstransmitter or transceiver of the TNP apparatus can communicate with awireless transceiver or receiver of the valves. In such examples, thewireless transceiver can communicate with each of the valves and iscapable of controlling each of the valves individually or as a unit.

At block 1008, the process monitors the pressure sensor 502 to determineif the selected dressing is experiencing an operating condition. Thisanalysis may be similar to a determination made by a process in anegative pressure system having a single wound dressing fluidicallyconnected to a negative pressure source. For example, a lower thanexpected negative pressure (or higher than expected flow) can indicatethat a wound dressing is experiencing leakage and a higher than expectednegative pressure (or lower than expected flow) can indicate that awound dressing is experiencing a blockage, overpressure, or dressingfull condition.

If the process determines that the selected wound dressing is notexperiencing an operating condition (for example, the pressure measuredby the pressure sensor 502 is generally equivalent to the expectedpressure), then a different fluid flow path/wound dressing is selectedfor testing. That is, the process 1000 returns to block 1006). The newlyselected fluid flow path/wound dressing will be a wound dressing thathas not been tested during the current diagnostic mode.

At block 1010, the process determines that the previously selected wounddressing is experiencing an operating condition. The valve associatedwith the selected wound dressing is closed (along with closing anyvalves associated with a fluid flow paths(s)/wound dressing(s)previously determined to be experiencing an operating condition). Allother valves are opened. As described above, the valves can be opened orclosed manually by a user or automatically by the controller.

At block 1012, the process monitors the pressure sensor to determine ifany of the fluid flow paths/wound dressings associated with open valvesare experiencing an operating condition. For example, the pressuresensor may sense an expected pressure (or flow) if no operatingconditions are present and may sense an unexpected pressure (or flow) ifoperating conditions are present. If the process determines that anoperating condition is present among the wound dressing(s) associatedwith the open valve(s), then a new wound dressing is selected (block1006). As described above, the newly selected wound dressing will be awound dressing that has not been tested during the current diagnosticmode.

At block 1014, the process has determined which flow paths/wounddressings of the plurality of wound dressings are experiencing anoperating condition. The process can provide appropriate indication asdescribed herein, which facilitates addressing and remedying theoperating condition. For example, if a dressing full operating conditionis detected, wound dressings can be replaced. In some examples, the usermust manually replace the wound dressings. In some examples, the wounddressings are replaced without the help of the user. At block 1014, allvalves can be opened, and the diagnostic mode has been completed. Asdescribed above, the valves can be opened manually orelectromechanically.

FIG. 11 illustrates a diagnostics process 1100 performed by a negativepressure wound treatment system 700 (see FIG. 7) according to someembodiments. Process 1100 can be performed by a controller of thenegative pressure wound treatment system. The process can monitor themeasured pressure and can determine whether any of the fluid flowpaths/wound dressings in the negative pressure system are experiencingan operating condition.

At block 1102, the process has determined that no operating conditionsexist within the negative pressure system. In some examples, one or moreLEDs or other indicators can be used to indicate to a user or caregiverthat no operating conditions exist. For example, each wound dressing canhave a corresponding LED that is ON when no operating condition isdetected on the associated wound dressing and OFF when an operatingcondition is detected on the associated wound dressing (or vice versa).In some examples, when no operating condition is detected in thenegative pressure system, all associated LEDs are ON. In some examples,other indicators may be associated with a no fault state (state in whichno operating conditions are detected), such as sounds, wirelessmessages, display notifications and/or other signals which may get theattention of a user or caregiver. In some examples, the TNP apparatusmay not provide an indication of no detected operating condition.

In some examples, the process continuously monitors the measuredpressure to determine if any of the fluid flow paths/wound dressingswithin the negative pressure system are experiencing an operatingcondition. In other examples, the process monitors the measuredpressured at predetermined intervals (such as, 1 minute, 2 minutes, 5minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, or 60 minutes).In some instances, the process monitors the pressure sensor responsiveto input by a user.

At block 1104, the process determines that an operating condition hasoccurred. As mentioned above, an operating condition can include ablockage, leakage, overpressure, dressing full condition, or the like.The process can detect one of the foregoing an operating conditionconditions by analysing the pressure measured by pressure sensor 502.For example, an operating condition can be determined based on a changein measured pressure (such as, spike, dip, increase, or decrease inmeasured pressure) or flow rate.

For instance, in a negative pressure system operating in a normal state(for example, where no fluid flow paths/wound dressings are experiencingan operating condition), the pressure sensor measures an “expectedpressure,” that is, a pressure equivalent (or almost equivalent) to aselected pressure to be supplied by the negative pressure source. Incontrast, when the negative pressure system is operating in a stateother than normal (such as one or more of the fluid flow paths/wounddressings are experiencing an operating condition), the pressure sensormeasures a pressure different from the expected pressure. In someexamples, a fluid flow path/wound dressing experiencing a blockage,overpressure, or dressing full condition, can cause the pressure sensorto measure a higher than expected pressure. In other examples, a fluidflow path/wound dressing experiencing a leakage condition can cause thepressure sensor to measure a lower than expected pressure. As describedherein, flow rate can be used to determine presence of an operatingcondition in some implementations.

At block 1106, and upon a determination that a wound dressing within thenegative pressure system is experiencing an operating condition, theprocess can provide indication of a detected operating condition. Forinstance, each wound dressing can have a corresponding LED. Upon thedetection of an operating condition, the process can cause each of theLEDs to flash. In other examples, other indicators are used in place ofor in supplement to LEDs. For example, a sound, wireless message,display notification and/or other signal can be used to indicate thatthe negative pressure system is experiencing an operating condition. Insome examples, the process can at least momentarily turn off thenegative pressure therapy system to indicate the system is experiencingan operating condition.

At block 1108, the process can suspend or wait to initiatetroubleshooting until it receives input from a user. For example, theprocess can detect that the system is experiencing an operatingcondition and provide an indication to the user or to a caregiver andwait until the process receives an acknowledgement. In some examples,the process immediately begins troubleshooting without waiting for inputfrom a user or begins troubleshooting after a delay.

At block 1110, a user acknowledges the determination that a fluid flowpath/wound dressing within the negative pressure system is experiencingan operating condition and provides input to the process to starttroubleshooting. In some instances, the user can press a button to startthe troubleshooting process. In other examples, the processautomatically starts the troubleshooting process immediately or after apredetermined interval of not receiving input from a user.

The user continues by selecting a fluid flow path/wound dressing totroubleshoot (for example, test for operating conditions). In someexamples, the user and/or the process can make this selection. Theselection of the fluid flow path/wound dressing can be based on avariety of factors including the user's suspicions, a suggestion by theprocess, and the like or a fluid flow path/wound dressing can bearbitrarily selection or selected based on an algorithm.

At block 1112, after a fluid flow path/wound dressing has been selectedfor testing, the valve associated with the selected flow path/dressingis opened and the valve(s) associated with the unselected flowpath(s)/dressing(s) are closed, thereby likening the negative therapysystem to a negative pressure system having a single wound dressing witha single negative pressure source. In some examples, the valve(s) can beopened or closed manually. In other examples, the valve(s) can operatedby a controller. For instance, the controller can wirelessly control theshut-off valves using a wireless transmitter or transceiver configuredto communicate with a wireless transceiver or receiver of the valves. Insome examples, a wireless transceiver can communicate with each of thevalves and is capable of controlling each of the valves individually oras a unit.

At block 1114, the user can indicate to the process that all valvesassociated with the unselected flow path(s)/dressing(s) are closed. Insome examples, the process can communicate with the valves to determinetheir status, and does not need input from a user. In some examples,such as when the valves are wirelessly controlled by the controller, theprocess does not wait for input from a user to open to close the valves.

At blocks 1116-1118, the process activates an operating conditiondetection scheme to determine whether or not the selected fluid flowpath/wound dressing is experiencing an operating condition. Thisanalysis is similar to a determination made by a process in a negativepressure system having a single wound dressing with a single negativepressure source. For example, a lower than expected negative pressure(or higher than expected flow) can indicate to that a fluid flowpath/wound dressing is experiencing leakage and a higher than expectednegative pressure (or lower than expected flow) can indicate that thefluid flow path/wound dressing is experiencing a blockage, overpressure,or dressing full condition. If the process determines that no operatingcondition is exists, the process moves to block 1130. If the processdetermines that an operating condition exists, then the process moves toblock 1120.

At block 1120, responsive to a determination that the selected fluidflow path/wound dressing is experiencing an operating condition, theprocess can provide indication to a user. For instance, the process cancause an LED associated with the selected wound dressing to turn ON orOFF.

At block 1122, the valve associated with the selected flow path/dressing(and any valves associated with other flow path(s)/wound dressing(s)previously determined to be experiencing an operating condition) isclosed and all other valves are opened. As mentioned above, the valvescan be manually opened or closed by a user or the controller. Duringthis step, all known fluid flow path(s)/wound dressing(s) experiencingan operating condition can be closed off from the negative pressuresource and only untested fluid flow path(s)/wound dressing(s) can remainin fluidic communication with the negative pressure source.

At block 1124, the process again activates an operating conditiondetection scheme, this time to determine whether any of the fluid flowpath(s)/wound dressing(s) in fluidic communication with the negativepressure source are experiencing an operating condition. For example,the process determines whether the measure pressure substantiallymatches the expected pressure (or flow substantially matches theexpected flow).

At step 1126, if no operating conditions are detected, the processcontinues to step 1134. If an operating condition is detected, theprocess continues to step 1128.

At step 1128, and upon a determination that at least one of theunselected or untested in step 1110 fluid flow path(s)/wound dressing(s)are experiencing an operating condition, the process can provideindication to the user. For examples, each wound dressing can have acorresponding LED. Upon the detection of an operating condition, theprocess can cause each of the LEDs associated with untested wounddressings to flash. In addition, the process can turn OFF each of theLEDs associated with wound dressings determined to be experiencing anoperating condition and turn ON each of the LEDs associated with wounddressings determined not to be experiencing an operating condition. Theprocess then returns to step 1108.

At step 1130, the process has determined that the selected fluid flowpath/wound dressing is not experiencing an operating condition. Theprocess can provide indication that the selected flow path/wounddressing is not experiencing an operating condition. For instance, theprocess and turn the associated LED ON (or green). In some examples,however, one of the remaining fluid flow path(s)/wound dressing(s) isexperiencing an operating condition.

At step 1132, a new fluid flow path/wound dressing is selected fortesting and the process returns to step 1112. The newly selected fluidflow path/wound dressing has not been tested during the currenttroubleshooting process (for example, has not been selected at block1110). As mentioned above, the wound dressing selection can be made bythe user and/or the process.

At step 1134, no operating conditions are detected on the fluid flowpath(s)/wound dressing(s) associated with the open valves. As such, thefluid flow path(s)/wound dressing(s) associated with closed valves havebeen determined to be experiencing an operating condition. In someembodiments, if the operating condition is a dressing full condition,the wound dressing(s) experiencing the operating condition are replacedand associated valve(s) are opened. In some examples, the user maymanually replace the wound dressings. In some examples, the user willknow which wound dressings need to be replaced based on an indication bythe process (for example, any OFF LED). In some instances, the userdetermines which wound dressings should be replaced by looking to seewhich wound dressings are associated with closed valves. In someexamples, the wound dressings are replaced without the help of the user.

At step 1136, the diagnostic mode ends. The process can continue to step1102 and continue to monitor the measured pressure.

In some cases, to aid in the troubleshooting process, a fluid flow pathcan be blocked, for example, by closing a valve or clamping the fluidflow path. The flow path can be blocked manually by a user orautomatically by a negative pressure wound treatment system. By closinga fluid flow path, the diagnostics process performed by the negativepressure wound treatment system can be simplified, for example, byreducing a number of dressing to troubleshoot. In addition oralternatively, closing a fluid flow path may allow a user to replace adressing without turning off the negative pressure wound treatmentsystem or otherwise stopping delivery of negative pressure to the otherwound dressings.

FIGS. 12A-12C illustrate portable negative pressure apparatusesaccording to some embodiments. As shown, the TNP apparatus 102 caninclude an outer housing 1210 for containing and/or supportingcomponents of the TNP apparatus 102.

The outer housing 1210 can include a display 1212 which can be designedto provide a user with information (for example, information regardingan operational status of the TNP apparatus 102). In some embodiments,the display 1212 can include one or more indicators, such as icons 1222(indicating normal operation), 1224 (indicating presence of one or moreleaks preventing the apparatus from providing negative pressure woundtherapy), 1226 (check dressing), and 1228 (low power reserve), which canalert the user to one or more operating and/or failure conditions of theTNP apparatus 102. The indicators can include icons for alerting theuser to normal or proper operating conditions, pump failure, powerfailure, the condition or voltage level of the batteries, the conditionor capacity of a wound dressing, detection of a leak within the dressingor fluid flow pathway between the dressing and the pump assembly,suction blockage, or any other similar or suitable conditions orcombinations thereof.

For example, the display 1212 can include a check dressing indicator1226, which can provide a user with an alert that prompts a user tocheck the wound dressing(s). In some cases, the alert will ensure thatfull or substantially full dressing(s) is(are) timely replaced. Forexample, a timer or reminder, which can be controlled by a processor ofthe TNP apparatus, can activate the check dressing indicator 1226 aftera predetermined period of time. For example, the check dressingindicator can be configured to activate once a day, such as every 24hours, or over other suitable duration of time. In some cases, a dailyreminder might be frequent enough to minimize a risk of woundmaceration, but it is not so frequent that it would become a nuisance tothe user. In some cases, the check dressing indicator 1226 can beactivated at convenient times for a user. For example, the indicator canbe activated at the time that fits with the user's daily life, such aswhen the user is getting dressed, showering, etc. In some cases, thedressing check indicator 1226 (or other indicators 1222, 1224, or 1228)can be reset by a single or double press of a button 1216 or by someother manipulation of the button 1216. For example, the check dressingindicator can deactivate upon the first press of the button 1216, whichwill pause the TNP apparatus 102. Such press of the button 1216 cansignal user's acknowledgment of the check dressing alert. The TNPapparatus 102 can then reinitiate provision of negative pressure on thesecond press of the button 1216.

In the illustrated embodiment, one or more icons 1222, 1224, 1226, 1228can be printed directly on the display 1212 of the outer housing 1210.In some embodiments, one or more of the icons 1222, 1224, 1226, 1228 canbe provided on a label attached to a portion of the outer housing 1210.One or more of the icons 1222, 1224, 1226, 1228 can be illuminated whenthe status corresponding to that icon exists in the system.

The TNP apparatus 102 can include one or more user input features, suchas the button 1216, designed to receive an input from the user forcontrolling the operation of the TNP apparatus 102. In the embodimentshown, a single button is present which can be used to activate anddeactivate the TNP apparatus 102 and/or control other operatingparameters of the TNP apparatus 102. For example, in some embodiments,the button 1216 can be used to activate the TNP apparatus 102, pause theTNP apparatus 102, clear indicators, such as any of icons 1222, 1224,1226, 1228, and/or be used for any other suitable purpose forcontrolling an operation of the TNP apparatus 102 (for example, bysequentially pushing on the button 1216). The button can be a push stylebutton that can be positioned on an outside, front surface of thehousing 1210. In other embodiments, multiple input features (forexample, multiple buttons) can be provided on the TNP apparatus 102.

In some embodiments, the TNP apparatus 102 can include a connector 1202for connecting a tube or conduit (such as an inlet manifold branchingattachment 206 or an integrated inlet manifold) to the TNP apparatus102. As illustrated in FIG. 12B, the connector 1202 can include twoconduits 602 and 604 for fluidically connecting the system to twoseparate wounds. In some embodiments, more than two wounds can beconnected to the TNP apparatus 102 via conduits conduits 602 and 604 orone or more additional conduits.

The system embodiments described herein can have a compact, small size.In some embodiments disclosed herein, a pump assembly of the system canhave a diameter (for example, equivalent diameter) or lateral sizebetween 15 mm and 35 mm, less than 15 mm, less than 25 mm, less than 35mm, or less than 50 mm. For example, in some embodiments, the system canhave a diameter or lateral size of 10 mm, 23 mm, or 40 mm, or can have adiameter or lateral size in the range of approximately 26 mm toapproximately 27 mm, between approximately 22 mm or smaller andapproximately 28 mm. In some embodiments disclosed herein, the systemcan have a thickness or height of approximately 8 mm, betweenapproximately 6 mm and approximately 10 mm, or a thickness or height ofless than 20 mm. For example, in some embodiments, the thickness orheight of the system can be 5 mm, 12 mm, or 20 mm.

In some examples, the TNP apparatus 102 can include a negative pressuresource configured to apply pressure for up to 7 days, 10 days, 30 days,and the like. The negative pressure source can include a motor, voicecoil actuator, piezoelectric actuator, and the like. In someembodiments, the TNP apparatus 102 can be battery powered (for instance,powered off two AA batteries).

In some embodiments, in addition to or instead of the one or moreindicators of the display 1212, the apparatus can provide one or moreaudible, tactile, haptic, or the like alerts.

FIG. 12C illustrates a portable negative pressure apparatus 1210 thatincorporates shut-off valves 1242, 1244 (sometimes referred to as a tap)in each fluid flow path according to some embodiments. As describedherein with respect to FIGS. 4A-4C, 5 or 7, a plurality of shut-offvalves 1242, 1244 can be positioned in the negative pressure therapysystem such that the closure of a valve blocks provision of negativepressure to an associated wound dressing. The shut-off valves 1242, 1244can be positioned anywhere in the fluid flow path, such as between theoutlets of the inlet manifold branching attachment (e.g., conduits 602and 604) and a corresponding dressing inlet or, in some cases, on orwithin the dressing. In some examples, as described herein with respectto FIGS. 4A-C, one or more shut-off valves 1242, 1244 can be integratedinto the inlet manifold branching attachment.

In some cases, one or more of the valves 1242, 1244 are manual shut-offvalves. For instance, a user can manually close the valve 1242 therebyblocking provision of negative pressure to the associated wounddressing. In other examples, one or more of the valves can be operatedby the system. For example, the valves can be electromechanical valves.For instance, a TNP apparatus can communicate with the valves to openand/or close each valve individually or as a unit. The communicationbetween the valves and the TNP apparatus can be wired or wireless. Forinstance, a wireless transceiver of the TNP apparatus can communicatewith a wireless transceiver of the valves.

FIGS. 12A-12G illustrate user interface displays 1212 for a portablenegative pressure apparatus according to some embodiments. A display1212 may have a combination of one or more of any of the indicators1222, 1224, 1226, 1228 illustrated in FIGS. 12A-12G. However, fewer,more, or different indicators are contemplated. For example, in somecases, a portable negative pressure apparatus may not include a displayand/or the display may not include any button or indicators.

FIG. 13 illustrates a perspective view of an embodiment of a wounddressing 1300 in conjunction with a fluidic connector 1310. Theillustrated wound dressing can be used with any of the embodiment ofnegative pressure systems described herein. As is illustrated, the wounddressing 1300 has an oval shaped absorbent layer 1320 having multiplelobes 1322. In some embodiments, the absorbent layer 1320 can have sixlobes. In some examples, two or more lobes 1322 (such as, six lobes) areprovided on the wound dressing 1300; the lobes 1322, and specifically,the gaps between the lobes 1322, aid the wound dressing 1300 inconforming to nonplanar wounds. For example, it may be advantageous touse the dressing 1300 to conform around joints such as elbows and knees.The dressing 1300 can have a rectangular or square shaped backing layer1324, and in some embodiments, the overall dressing 1300 may measure 190mm×230 mm, or 145.5 mm×4100 mm.

In some examples, the dressing 1300 may also have circular cutouts 1328in a central-waisted portion, which may be located along a midline ofthe dressing 1300 transverse to a longitudinal axis of the dressing1300. Such cutouts 1328 may be, in some embodiments, 10 mm, orapproximately 10 mm, in diameter, or may be in the range of 5 mm to 25mm, or approximately 5 mm to approximately 25 mm, in diameter. Asillustrated, the circular cutouts 1328 can be symmetrically arranged onopposite sides of a longitudinal midline of the dressing 1300, and mayform an arc of greater than 180 degrees, sometimes between 180 and 270(or about 180 to 270) degrees.

As illustrated, the fluidic connector 1310 may include an elongateconduit, or a bridge 1320 having a proximal end 1330 and a distal end1340, and an applicator 1380 at the distal end 1340 of the bridge 1320.In some examples, the bridge 1320 provides a soft, fluidic connectionbetween the tube 1390 and the wound dressing 1300 and can advantageouslydistance the tube 1390 from wound dressing 1300, thereby reducing thepotential for pressure points caused by the tube 1390. In some examples,the length of the bridge 1320 can be 20, 30, 45, 60, or 70 centimeters(+/−a few centimeters). An optional coupling 1360 can be disposed at theproximal end 1330 of the bridge 1320. In some examples, a cap (notshown) can be attached to the coupling 1360 and can be useful inpreventing fluids from leaking out of the proximal end 1330.

A negative pressure system (such as the one illustrated in FIGS.12A-12C) may be connected to the coupling 1360 via a tube 1390 (such asby connecting the tube 1390 to one of the connectors 602 or 604), or thesystem may be connected directly to the coupling 1360 or directly to thebridge 1320. In use, the dressing 1300 is placed over a suitablyprepared wound, which may in some cases be filled with a wound packingmaterial such as foam or gauze. The applicator 1380 of the fluidicconnector 1310 has a sealing surface that is placed over an aperture inthe dressing 1300 and is sealed to the top surface of the dressing 1300.Either before, during, or after connection of the fluidic connector 1310to the dressing 1300, a system is connected via the tube 1390 to thecoupling 1360, or is connected directly to the coupling 1360 or to thebridge 1320. The system is then activated, thereby supplying negativepressure to the wound. Application of negative pressure may be applieduntil a desired level of healing of the wound is achieved. In someembodiments, the system can be miniaturized and portable, althoughlarger conventional pumps may also be used with the dressing 1300. Insome embodiments, the system may be attached or mounted within, onto, oradjacent the dressing 1300.

In some embodiments, a source of negative pressure (such as a pump) andsome or all other components of a TNP system, such as power source(s),sensor(s), connector(s), user interface component(s) (such as button(s),switch(es), speaker(s), screen(s), etc.) and the like, can be integralwith the wound dressing 1300. The wound dressing 1300 can include acover layer for positioning over the layers of the wound dressing. Thecover layer can be the upper most layer of the dressing. In someembodiments, the wound dressing 1300 can include a second cover layerfor positioning over the layers of the wound dressing and any of theintegrated components. The second cover layer can be the upper mostlayer of the dressing or can be a separate envelope that encloses theintegrated components of the topical negative pressure system.

As shown in FIG. 13, the fluidic connector 1310 includes an enlargeddistal end, or head 1340 that is in fluidic communication with thedressing 1300 as will be described in further detail below. In oneembodiment, the enlarged distal end has a round or circular shape. Thehead 1340 is illustrated here as being positioned near an edge of thedressing 1300, but may also be positioned at any location on thedressing. For example, some embodiments may provide for a centrally oroff-centered location not on or near an edge or corner of the dressing1300. In some embodiments, the dressing 1300 may include two or morefluidic connectors 1310, each having one or more heads 1340, in fluidiccommunication therewith. In an embodiment, the head 1340 may measure 30mm along its widest edge. The head 1340 forms at least in part theapplicator 1380, described above, that is configured to seal against atop surface of the wound dressing.

FIG. 14 illustrates a cross-section through a wound dressing 1400similar to the wound dressing 1300 as shown in FIG. 13 along withfluidic connector 1410. The wound dressing 1400, which can alternativelybe any wound dressing embodiment disclosed herein or any combination offeatures of any number of wound dressing embodiments disclosed herein,can be located over a wound site to be treated. The dressing 1400 can beused with any of the negative pressure system embodiment describedherein. The dressing 1400 may be placed as to form a sealed cavity overthe wound site. In an embodiment, the dressing 1400 includes a top orcover layer, or backing layer 1420 attached to an optional wound contactlayer 1422, both of which are described in greater detail below. Thesetwo layers 1420, 1422 can be joined or sealed together to define aninterior space or chamber. This interior space or chamber may includeadditional structures that may be adapted to distribute or transmitnegative pressure, store wound exudate and other fluids removed from thewound, and other functions that will be explained in detail below.Examples of such structures, described below, include a transmissionlayer 1426 and an absorbent layer 1421.

As used herein the upper layer, top layer, or layer above refers to alayer furthest from the surface of the skin or wound while the dressingis in use and positioned over the wound. Accordingly, the lower surface,lower layer, bottom layer, or layer below refers to the layer that isclosest to the surface of the skin or wound while the dressing is in useand positioned over the wound.

As illustrated in FIG. 14, the wound contact layer 1422 can be apolyurethane layer or polyethylene layer or other flexible layer whichis perforated, for example via a hot pin process, laser ablationprocess, ultrasound process or in some other way or otherwise madepermeable to liquid and gas. The wound contact layer 1422 has a lowersurface 1424 and an upper surface 1423. The perforations 1425 caninclude through holes in the wound contact layer 1422 that enable fluidto flow through the layer 1422. The wound contact layer 1422 helpsprevent tissue ingrowth into the other material of the wound dressing.The perforations can be small enough to meet this requirement whilestill allowing fluid to flow therethrough. For example, perforationsformed as slits or holes having a size ranging from 0.025 mm to 1.2 mmare considered small enough to help prevent tissue ingrowth into thewound dressing while allowing wound exudate to flow into the dressing.In some configurations, the wound contact layer 1422 may help maintainthe integrity of the entire dressing 1400 while also creating anairtight seal around the absorbent pad in order to maintain negativepressure at the wound.

Some embodiments of the wound contact layer 1422 may also act as acarrier for an optional lower and upper adhesive layer (not shown). Forexample, a lower pressure sensitive adhesive may be provided on thelower surface 1424 of the wound dressing 1400 whilst an upper pressuresensitive adhesive layer may be provided on the upper surface 1423 ofthe wound contact layer. The pressure sensitive adhesive, which may be asilicone, hot melt, hydrocolloid or acrylic based adhesive or other suchadhesives, may be formed on both sides or optionally on a selected oneor none of the sides of the wound contact layer. When a lower pressuresensitive adhesive layer is utilized may be helpful to adhere the wounddressing 1400 to the skin around a wound site. In some embodiments, thewound contact layer may include perforated polyurethane film. The lowersurface of the film may be provided with a silicone pressure sensitiveadhesive and the upper surface may be provided with an acrylic pressuresensitive adhesive, which may help the dressing maintain its integrity.In some embodiments, a polyurethane film layer may be provided with anadhesive layer on both its upper surface and lower surface, and allthree layers may be perforated together.

A layer 1426 of porous material can be located above the wound contactlayer 1422. This porous layer, or transmission layer, 1426 allowstransmission of fluid including liquid and gas away from a wound siteinto upper layers of the wound dressing. In particular, the transmissionlayer 1426 can ensure that an open air channel can be maintained tocommunicate negative pressure over the wound area even when theabsorbent layer has absorbed substantial amounts of exudates. The layer1426 can remain open under the typical pressures that will be appliedduring negative pressure wound therapy as described above, so that thewhole wound site sees an equalized negative pressure. The layer 1426 maybe formed of a material having a three dimensional structure. Forexample, a knitted or woven spacer fabric (for example Baltex 7970 weftknitted polyester) or a non-woven fabric could be used.

In some embodiments, the transmission layer 1426 includes a 3D polyesterspacer fabric layer including a top layer (that is to say, a layerdistal from the wound-bed in use) which is a 84/144 textured polyester,and a bottom layer (that is to say, a layer which lies proximate to thewound bed in use) which is a 10 denier flat polyester and a third layerformed sandwiched between these two layers which is a region defined bya knitted polyester viscose, cellulose or the like mono filament fiber.Other materials and other linear mass densities of fiber could of coursebe used.

Whilst reference is made throughout this disclosure to a monofilamentfiber it will be appreciated that a multistrand alternative could ofcourse be utilized. The top spacer fabric thus has more filaments in ayarn used to form it than the number of filaments making up the yarnused to form the bottom spacer fabric layer.

This differential between filament counts in the spaced apart layershelps control moisture flow across the transmission layer. Particularly,by having a filament count greater in the top layer, that is to say, thetop layer is made from a yarn having more filaments than the yarn usedin the bottom layer, liquid tends to be wicked along the top layer morethan the bottom layer. In use, this differential tends to draw liquidaway from the wound bed and into a central region of the dressing wherethe absorbent layer 1421 helps lock the liquid away or itself wicks theliquid onwards towards the cover layer where it can be transpired.

To improve the liquid flow across the transmission layer 1426 (that isto say perpendicular to the channel region formed between the top andbottom spacer layers, the 3D fabric may be treated with a dry cleaningagent (such as, but not limited to, Perchloro Ethylene) to help removeany manufacturing products such as mineral oils, fats and/or waxes usedpreviously which might interfere with the hydrophilic capabilities ofthe transmission layer. In some embodiments, an additional manufacturingstep can subsequently be carried in which the 3D spacer fabric is washedin a hydrophilic agent (such as, but not limited to, Feran Ice 30 g/lavailable from the Rudolph Group). This process step helps ensure thatthe surface tension on the materials is so low that liquid such as watercan enter the fabric as soon as it contacts the 3D knit fabric. Thisalso aids in controlling the flow of the liquid insult component of anyexudates.

A layer 1421 of absorbent material is provided above the transmissionlayer 1426. The absorbent material, which includes a foam or non-wovennatural or synthetic material, and which may optionally include asuper-absorbent material, forms a reservoir for fluid, particularlyliquid, removed from the wound site. In some embodiments, the layer 1421may also aid in drawing fluids towards the backing layer 1420.

The material of the absorbent layer 1421 may also prevent liquidcollected in the wound dressing 1400 from flowing freely within thedressing, and can act so as to contain any liquid collected within thedressing. The absorbent layer 1421 also helps distribute fluidthroughout the layer via a wicking action so that fluid is drawn fromthe wound site and stored throughout the absorbent layer. This helpsprevent agglomeration in areas of the absorbent layer. The capacity ofthe absorbent material must be sufficient to manage the exudates flowrate of a wound when negative pressure is applied. Since in use theabsorbent layer experiences negative pressures the material of theabsorbent layer is chosen to absorb liquid under such circumstances. Anumber of materials exist that are able to absorb liquid when undernegative pressure, for example superabsorber material. The absorbentlayer 1421 may typically be manufactured from ALLEVYN™ foam, Freudenberg114-224-4 and/or Chem-Posite™11C-450. In some embodiments, the absorbentlayer 1421 may include a composite having superabsorbent powder, fibrousmaterial such as cellulose, and bonding fibers. In an embodiment, thecomposite is an airlaid, thermally-bonded composite.

In some embodiments, the absorbent layer 1421 is a layer of non-wovencellulose fibers having super-absorbent material in the form of dryparticles dispersed throughout. Use of the cellulose fibers introducesfast wicking elements which help quickly and evenly distribute liquidtaken up by the dressing. The juxtaposition of multiple strand-likefibers leads to strong capillary action in the fibrous pad which helpsdistribute liquid. In this way, the super-absorbent material isefficiently supplied with liquid. The wicking action also assists inbringing liquid into contact with the upper cover layer to aid increasetranspiration rates of the dressing.

An aperture, hole, or orifice 1427 can be provided in the backing layer1420 to allow a negative pressure to be applied to the dressing 1400.The fluidic connector 1410 can be attached or sealed to the top of thebacking layer 1420 over the orifice 1427 made into the dressing 1400,and communicates negative pressure through the orifice 1427. A length oftubing may be coupled at a first end to the fluidic connector 1410 andat a second end to a negative pressure system (not shown) to allowfluids to be removed from the dressing. Where the fluidic connector isadhered to the top layer of the wound dressing, a length of tubing maybe coupled at a first end of the fluidic connector such that the tubing,or conduit, extends away from the fluidic connector parallel orsubstantially to the top surface of the dressing. The fluidic connector1410 may be adhered and sealed to the backing layer 1420 using anadhesive such as an acrylic, cyanoacrylate, epoxy, UV curable or hotmelt adhesive. The fluidic connector 1410 may be formed from a softpolymer, for example a polyethylene, a polyvinyl chloride, a silicone orpolyurethane having a hardness of 30 to 90 on the Shore A scale. In someembodiments, the fluidic connector 1410 may be made from a soft orconformable material.

The absorbent layer 1421 can include at least one through hole 1428located so as to underlie the fluidic connector 1410. The through hole1428 may in some embodiments be the same size as the opening 1427 in thebacking layer, or may be bigger or smaller. As illustrated in FIG. 14 asingle through hole can be used to produce an opening underlying thefluidic connector 1410. It will be appreciated that multiple openingscould alternatively be utilized. Additionally should more than one portbe utilized according to certain embodiments of the present disclosureone or multiple openings may be made in the absorbent layer and theobscuring layer in registration with each respective fluidic connector.Although not essential to certain embodiments of the present disclosurethe use of through holes in the super-absorbent layer may provide afluid flow pathway which remains unblocked in particular when theabsorbent layer is near saturation.

The aperture or through-hole 1428 can be provided in the absorbent layer1421 beneath the orifice 1427 such that the orifice is connecteddirectly to the transmission layer 1426 as illustrated in FIG. 14. Thisallows the negative pressure applied to the fluidic connector 1410 to becommunicated to the transmission layer 1426 without passing through theabsorbent layer 1421. This ensures that the absorbent layer does notinhibit the negative pressure applied to the wound site as it absorbswound exudates. In other embodiments, no aperture may be provided in theabsorbent layer 1421, or alternatively a plurality of aperturesunderlying the orifice 1427 may be provided. In further alternativeembodiments, additional layers may be provided over the absorbent layer1421 and beneath the backing layer 1420.

The backing layer 1420 can be gas impermeable, but moisture vaporpermeable, and can extend across the width of the wound dressing 1400.The backing layer 1420, which may for example be a polyurethane film(for example, Elastollan SP9109) having a pressure sensitive adhesive onone side, is impermeable to gas and this layer thus operates to coverthe wound and to seal a wound cavity over which the wound dressing isplaced. In this way an effective chamber is made between the backinglayer 1420 and a wound site where a negative pressure can beestablished. The backing layer 1420 can be sealed to the wound contactlayer 1422 in a border region around the circumference of the dressing,ensuring that no air is drawn in through the border area, for examplevia adhesive or welding techniques. The backing layer 1420 protects thewound from external bacterial contamination (bacterial barrier) andallows liquid from wound exudates to be transferred through the layerand evaporated from the film outer surface. The backing layer 1420 caninclude two layers; a polyurethane film and an adhesive pattern spreadonto the film. The polyurethane film can be moisture vapor permeable andmay be manufactured from a material that has an increased watertransmission rate when wet. In some embodiments, the moisture vaporpermeability of the backing layer increases when the backing layerbecomes wet. The moisture vapor permeability of the wet backing layermay be up to about ten times more than the moisture vapor permeabilityof the dry backing layer.

The absorbent layer 1421 may be of a greater area than the transmissionlayer 1426, such that the absorbent layer overlaps the edges of thetransmission layer 1426, thereby ensuring that the transmission layerdoes not contact the backing layer 1420. This provides an outer channelof the absorbent layer 1421 that is in direct contact with the woundcontact layer 1422, which aids more rapid absorption of exudates to theabsorbent layer. Furthermore, this outer channel ensures that no liquidis able to pool around the circumference of the wound cavity, whichcould seep through the seal around the perimeter of the dressing leadingto the formation of leaks. As illustrated in FIG. 14, the absorbentlayer 1421 may define a smaller perimeter than that of the backing layer1420, such that a boundary or border region is defined between the edgeof the absorbent layer 1421 and the edge of the backing layer 1420.

As shown in FIG. 14, one embodiment of the wound dressing 1400 includesan aperture 1428 in the absorbent layer 1421 situated underneath thefluidic connector 1410. In use, for example when negative pressure isapplied to the dressing 1400, a wound facing portion of the fluidicconnector may thus come into contact with the transmission layer 1426,which can thus aid in transmitting negative pressure to the wound siteeven when the absorbent layer 1421 is filled with wound fluids. Someembodiments may have the backing layer 1420 be at least partly adheredto the transmission layer 1426. In some embodiments, the aperture 1428is at least 1-2 mm larger than the diameter of the wound facing portionof the fluidic connector 1410, or the orifice 1427.

In particular for embodiments with a single fluidic connector 1410 andthrough hole, the fluidic connector 1410 and through hole can be locatedin an off-center position as illustrated in FIG. 13. Such a location maypermit the dressing 1400 to be positioned onto a patient such that thefluidic connector 1410 is raised in relation to the remainder of thedressing 1400. So positioned, the fluidic connector 1410 and the filter1414 may be less likely to come into contact with wound fluids thatcould prematurely occlude the filter 1414 so as to impair thetransmission of negative pressure to the wound site.

Turning now to the fluidic connector 1410, some embodiments include asealing surface 1416, a bridge 1411 (corresponding to bridge 1320) inFIG. 13) with a proximal end 1330 and a distal end 1340, and a filter1414. The sealing surface 1416 can form the applicator previouslydescribed that is sealed to the top surface of the wound dressing. Insome embodiments a bottom layer of the fluidic connector 1410 mayinclude the sealing surface 1416. The fluidic connector 1410 may furtherinclude an upper surface vertically spaced from the sealing surface1416, which in some embodiments is defined by a separate upper layer ofthe fluidic connector. In other embodiments the upper surface and thelower surface may be formed from the same piece of material. In someembodiments the sealing surface 1416 may include at least one aperture1429 therein to communicate with the wound dressing. In some embodimentsthe filter 1414 may be positioned across the opening 1429 in the sealingsurface, and may span the entire opening 1429. The sealing surface 1416may be configured for sealing the fluidic connector to the cover layerof the wound dressing, and may include an adhesive or weld. In someembodiments, the sealing surface 1416 may be placed over an orifice inthe cover layer. In other embodiments, the sealing surface 1416 may bepositioned over an orifice in the cover layer and an aperture in theabsorbent layer 1420, permitting the fluidic connector 1410 to provideair flow through the transmission layer 1426. In some embodiments, thebridge 1411 may include a first fluid passage 1412 in communication witha source of negative pressure, the first fluid passage 1412 including aporous material, such as a 3D knitted material, which may be the same ordifferent than the porous layer 1426 described previously. The bridge1411 can be encapsulated by at least one flexible film layer 1408, 1410having a proximal and distal end and configured to surround the firstfluid passage 1412, the distal end of the flexible film being connectedto the sealing surface 1416. The filter 1414 is configured tosubstantially prevent wound exudate from entering the bridge.

Some embodiments may further include an optional second fluid passagepositioned above the first fluid passage 1412. For example, someembodiments may provide for an air leak disposed at the proximal end ofthe top layer 1408 that is configured to provide an air path into thefirst fluid passage 1412 and dressing 1400.

The fluid passage 1412 can be constructed from a compliant material thatis flexible and that also permits fluid to pass through it if the spaceris kinked or folded over. Suitable materials for the fluid passage 1412include without limitation foams, including open-cell foams such aspolyethylene or polyurethane foam, meshes, 3D knitted fabrics, non-wovenmaterials, and fluid channels. In some embodiments, the fluid passage1412 may be constructed from materials similar to those described abovein relation to the transmission layer 1426. Advantageously, suchmaterials used in the fluid passage 1412 not only permit greater patientcomfort, but may also provide greater kink resistance, such that thefluid passage 1412 is still able to transfer fluid from the wound towardthe source of negative pressure while being kinked or bent.

In some embodiments, the fluid passage 1412 may include a wickingfabric, for example a knitted or woven spacer fabric (such as a knittedpolyester 3D fabric, Baltex 7970®, or Gehring 879®) or a nonwovenfabric. These materials selected can be suited to channeling woundexudate away from the wound and for transmitting negative pressureand/or vented air to the wound site, and may also confer a degree ofkinking or occlusion resistance to the fluid passage 1412. In someembodiments, the wicking fabric may have a three-dimensional structure,which in some cases may aid in wicking fluid or transmitting negativepressure. In certain embodiments, including wicking fabrics, thesematerials remain open and capable of communicating negative pressure toa wound area under the typical pressures used in negative pressuretherapy, for example between 40 to 150 mmHg. In some embodiments, thewicking fabric may include several layers of material stacked or layeredover each other, which may in some cases be useful in preventing thefluid passage 1412 from collapsing under the application of negativepressure. In other embodiments, the wicking fabric used in the fluidpassage 1412 may be between 1.5 mm and 6 mm; or the wicking fabric maybe between 3 mm and 6 mm thick, and may include either one or severalindividual layers of wicking fabric. In other embodiments, the fluidpassage 1412 may be between 1.2-3 mm thick, for example, thicker than1.5 mm Some embodiments, for example a suction adapter used with adressing which retains liquid such as wound exudate, may employhydrophobic layers in the fluid passage 1412, and only gases may travelthrough the fluid passage 1412. Additionally, and as describedpreviously, the materials used in the system can be conformable andsoft, which may help to avoid pressure ulcers and other complicationswhich may result from a wound treatment system being pressed against theskin of a patient.

The filter element 1414 can be impermeable to liquids, but permeable togases, and is provided to act as a liquid bather and to ensure that noliquids are able to escape from the wound dressing 1400. The filterelement 1414 may also function as a bacterial barrier. Typically thepore size is 0.2 μm. Suitable materials for the filter material of thefilter element 1414 include 0.2 micron Gore™ expanded PTFE from the MMTrange, PALL Versapore™ 200R, and Donaldson™ TX6628. Larger pore sizescan also be used but these may require a secondary filter layer toensure full bioburden containment. As wound fluid contains lipids, anoleophobic filter membrane can be used, for example 1.0 micron MMT-332prior to 0.2 micron MMT-323. This prevents the lipids from blocking thehydrophobic filter. The filter element can be attached or sealed to theport and/or the cover film over the orifice. For example, the filterelement 1414 may be molded into the fluidic connector 1410, or may beadhered to one or both of the top of the cover layer and bottom of thesuction adapter 1410 using an adhesive such as, but not limited to, a UVcured adhesive.

It will be understood that other types of material could be used for thefilter element 1414. More generally a microporous membrane can be usedwhich is a thin, flat sheet of polymeric material, this containsbillions of microscopic pores. Depending upon the membrane chosen thesepores can range in size from 0.01 to more than 10 micrometers.Microporous membranes are available in both hydrophilic (waterfiltering) and hydrophobic (water repellent) forms. In some embodimentsof the present disclosure, filter element 1414 includes a support layerand an acrylic co-polymer membrane formed on the support layer. Thewound dressing 1400 according to certain embodiments of the presentdisclosure can use microporous hydrophobic membranes (MHMs). Numerouspolymers may be employed to form MHMs. For example, the MHMs may beformed from one or more of PTFE, polypropylene, PVDF and acryliccopolymer. All of these optional polymers can be treated in order toobtain specific surface characteristics that can be both hydrophobic andoleophobic. As such these will repel liquids with low surface tensionssuch as multi-vitamin infusions, lipids, surfactants, oils and organicsolvents.

MHMs block liquids whilst allowing air to flow through the membranes.They are also highly efficient air filters eliminating potentiallyinfectious aerosols and particles. A single piece of MHM is well knownas an option to replace mechanical valves or vents. Incorporation ofMHMs can thus reduce product assembly costs improving profits andcosts/benefit ratio to a patient.

The filter element 1414 may also include an odor absorbent material, forexample activated charcoal, carbon fiber cloth or Vitec Carbotec-RTQ2003073 foam, or the like. For example, an odor absorbent material mayform a layer of the filter element 1414 or may be sandwiched betweenmicroporous hydrophobic membranes within the filter element. The filterelement 1414 thus enables gas to be exhausted through the orifice.Liquid, particulates and pathogens however are contained in thedressing.

Similar to the embodiments of wound dressings described above, somewound dressings include a perforated wound contact layer with siliconeadhesive on the skin-contact face and acrylic adhesive on the reverse.Above this bordered layer sits a transmission layer or a 3D spacerfabric pad. Above the transmission layer, sits an absorbent layer. Theabsorbent layer can include a superabsorbent non-woven (NW) pad. Theabsorbent layer can over-border the transmission layer by approximately5 mm at the perimeter. The absorbent layer can have an aperture orthrough-hole toward one end. The aperture can be about 10 mm indiameter. Over the transmission layer and absorbent layer lays a backinglayer. The backing layer can be a high moisture vapor transmission rate(MVTR) film, pattern coated with acrylic adhesive. The high MVTR filmand wound contact layer encapsulate the transmission layer and absorbentlayer, creating a perimeter border of approximately 20 mm. The backinglayer can have a 10 mm aperture that overlies the aperture in theabsorbent layer. Above the hole can be bonded a fluidic connector thatincludes a liquid-impermeable, gas-permeable semi-permeable membrane(SPM) or filter that overlies the aforementioned apertures.

FIGS. 15A-15D illustrate embodiments of a wound dressing incorporatingnegative pressure indicators according to some embodiments. FIG. 15Aillustrates negative pressure indicators 1591 on or within the wounddressing 1500 to indicate when negative pressure is established underthe dressing. The negative pressure indicator 1591 can be a mechanicalindicator. In some embodiments, the negative pressure indicator 1591 canbe an indicator that does not require direct line of sight from thepatient. For example, the negative pressure indicator 1591 can be anindicator that can be touched or felt by a patient or user. The negativepressure indicator 1591 can be one or more apertures or cut outs in anabsorbent material of the dressing. In some cases, once negativepressure is applied under a cover layer, the dressing can tighten andthe cover layer can compress as it sucks down into the one or moreapertures or cut outs in the absorbent material.

In some embodiments, the negative pressure indicators 1591 can be asmall hole array as illustrated in FIG. 15A. In some embodiments, therecan be three small holes in the dressing. In some embodiments, two setsof three small hole arrays can be used on opposite sides of the dressingextending longitudinally along the side edges of the dressing as shownin FIG. 15A. In some embodiments, an individual negative pressureindicator can be about 4 mm to about 5 mm in diameter.

The negative pressure indicators can be formed from different types ofstep changes or indentations created in the dressing as a result of acut out or hole in the absorbent layer. In some embodiments, thenegative pressure indicators can be formed from the hole or cut out inthe absorbent material with the cover layer covering the hole or cutout. In some embodiments, the hole or cut out in the absorbent materialcan be circular, rectangular, triangular, oval, or any other shape. Whenno vacuum is applied the area can feel loose, whilst under negativepressure the area can tighten and the stepped topography or indentationin the cover layer can be apparent. The stepped topography can bevisualized and/or felt by the user. A small hole in the absorbentmaterial as illustrated in FIG. 15A can be used. In other embodiments, alarge hole in the absorbent material coupled with another film materialor a rectangular strip in the absorbent material coupled with anotherfilm material can be used.

The small hole cut in the absorbent material can be used in combinationwith the adhesive coated top film. The interaction between the twobehave as described previously. Under pressure the absorbent materialcompresses and the film tightens revealing a film covered hole. Thishole can be felt when the system is under negative pressure. When thesystem returns to ambient pressure, the film “relaxes” or “springs” backto its original state and the hole cannot be as easily felt through thetop film material. FIGS. 15B-15C illustrate cross sectional views of theholes before (FIG. 15B) and during (FIG. 15C) negative pressureapplication. The small hole (about 4 mm to about 5 mm in diameter)negative pressure indicators can allow for a tight step changetopography when negative pressure is applied whilst hiding the steppedhole area when the dressing is returned to ambient pressure.

In other embodiments, a large hole with a non-adhesive film can be usedas a negative pressure indicator. The large hole can be an aperture orcut out as described with the small holes. However, since the coverlayer can be coated with an adhesive material, a non-adhesive film 1592can be used within the large hole in the absorbent material 1522 toprevent the cover layer 1513 from remaining fixed to the lower layers ofthe dressing after the cover layer 1513 has been compressed down intothe large hole and then returned to ambient pressure.

FIG. 15D illustrates a cross sectional view of an embodiment of a wounddressing with a negative pressure indicator 1591 with a large holeaperture in the absorbent material 1522. When the system is undernegative pressure, the cover layer 1513 can stick to the non-adhesivefilm material 1592 and tighten around the absorbent material 1522creating the step change topography in the dressing defining thenegative pressure indicator 1591. Once the dressing returns to ambientpressure, the cover layer 1513 can relax back to its original state. Insome embodiments, the large hole can be a circular hole of 12 mm (about12 mm) in diameter. In some embodiments, more than one large hole can beused. In some embodiments, an array of large holes can be used. In someembodiments, the holes can be less than 3 mm, 3 mm (about 3 mm), 4 mm(about 4 mm), 5 mm (about 5 mm), 6 mm (about 6 mm), 7 mm (about 7 mm),or greater than 7 mm in diameter.

Terminology

Depending on the embodiment, certain operations, acts, events, orfunctions of any of the processes described herein can be performed in adifferent sequence, can be added, merged, or left out altogether (suchas not all are necessary for the practice of the processes). Moreover,in certain embodiments, operations, acts, functions, or events can beperformed concurrently, such as through multi-threaded processing,interrupt processing, or multiple processors or processor cores or onother parallel architectures, rather than sequentially.

The processing of the various components of the illustrated systems canbe distributed across multiple machines, networks, and other computingresources. In addition, two or more components of a system can becombined into fewer components. Various components of the illustratedsystems can be implemented in one or more virtual machines, rather thanin dedicated computer hardware systems and/or computing devices.Likewise, the data repositories shown can represent physical and/orlogical data storage, including, for example, storage area networks orother distributed storage systems. Moreover, in some embodiments theconnections between the components shown represent possible paths ofdata flow, rather than actual connections between hardware. While someexamples of possible connections are shown, any of the subset of thecomponents shown can communicate with any other subset of components invarious implementations.

Any patents and applications and other references noted above, includingany that may be listed in accompanying filing papers, are incorporatedherein by reference. Aspects of the disclosure can be modified, ifnecessary, to employ the systems, functions, and concepts of the variousreferences described herein to provide yet further implementations.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example describedherein unless incompatible therewith. All of the features disclosed inthis specification (including any accompanying claims, abstract anddrawings), or all of the steps of any method or process so disclosed,may be combined in any combination, except combinations where at leastsome of such features or steps are mutually exclusive. The protection isnot restricted to the details of any foregoing embodiments. Theprotection extends to any novel one, or any novel combination, of thefeatures disclosed in this specification (including any accompanyingclaims, abstract and drawings), or to any novel one, or any novelcombination, of the steps of any method or process so disclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems describedherein may be embodied in a variety of other forms. Furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made. Those skilled in the art willappreciate that in some embodiments, the actual steps taken in theprocesses illustrated or disclosed may differ from those shown in thefigures. Depending on the embodiment, certain of the steps describedabove may be removed, others may be added. For example, the actual stepsor order of steps taken in the disclosed processes may differ from thoseshown in the figure. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. For instance, thevarious components illustrated in the figures may be implemented assoftware or firmware on a processor, controller, ASIC, FPGA, ordedicated hardware. Hardware components, such as processors, ASICs,FPGAs, and the like, can include logic circuitry. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure.

Although the present disclosure includes certain embodiments, examplesand applications, it will be understood by those skilled in the art thatthe present disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments or uses and obviousmodifications and equivalents thereof, including embodiments which donot provide all of the features and advantages set forth herein.Accordingly, the scope of the present disclosure is not intended to belimited by the described embodiments, and may be defined by claims aspresented herein or as presented in the future.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, or steps are in anyway required for one or more embodiments or that one or more embodimentsnecessarily include logic for deciding, with or without user input orprompting, whether these features, elements, or steps are included orare to be performed in any particular embodiment. The terms“comprising,” “including,” “having,” and the like are synonymous and areused inclusively, in an open-ended fashion, and do not excludeadditional elements, features, acts, operations, and so forth. Also, theterm “or” is used in its inclusive sense (and not in its exclusivesense) so that when used, for example, to connect a list of elements,the term “or” means one, some, or all of the elements in the list.Likewise the term “and/or” in reference to a list of two or more items,covers all of the following interpretations of the word: any one of theitems in the list, all of the items in the list, and any combination ofthe items in the list. Further, the term “each,” as used herein, inaddition to having its ordinary meaning, can mean any subset of a set ofelements to which the term “each” is applied. Additionally, the words“herein,” “above,” “below,” and words of similar import, when used inthis application, refer to this application as a whole and not to anyparticular portions of this application.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

Any of the embodiments described herein can be used with a canister orwithout a canister. Any of the dressing embodiments described herein canabsorb and store wound exudate.

The scope of the present disclosure is not intended to be limited by thedescription of certain embodiments and may be defined by the claims. Thelanguage of the claims is to be interpreted broadly based on thelanguage employed in the claims and not limited to the examplesdescribed in the present specification or during the prosecution of theapplication, which examples are to be construed as non-exclusive.

1-66. (canceled)
 67. A method of determining a blockage in a negativepressure wound therapy system, the method comprising, by a controller:receiving first pressure data indicative of a combined pressure in aplurality of fluid flow paths fluidically connecting a negative pressuresource with a plurality of wound dressings, wherein the plurality offluid flow paths comprises at least a first fluid flow path including afirst valve and a second fluid flow path including a second valve; basedon a determination that the first pressure data satisfies a firstblockage threshold, determining that the plurality of fluid flow pathsincludes a fluid flow path associated with a blockage condition; andbased at least in part on the second pressure data, identifying at leastone fluid flow path of the plurality of fluid flow paths that isassociated with the blockage condition, wherein the second pressure datais obtained when at least one of the first valve or the second valve isclosed.
 68. The method of claim 67, wherein the first blockage thresholdcorresponds to an expected combined negative pressure of the pluralityof fluid flow paths when at least one of the plurality of fluid flowpaths is associated with the blockage condition.
 69. The method of claim67, wherein said identifying comprises: causing the second valve to beclosed; and determining that the first fluid flow path is associatedwith the blockage condition based at least in part on determining thatthe second pressure data obtained when the first valve is open and thesecond valve is closed satisfies a second blockage threshold.
 70. Themethod of claim 69, wherein the second blockage threshold corresponds toan expected negative pressure of a single fluid flow path that is notassociated with the blockage condition.
 71. The method of claim 67,further comprising, by the controller: causing the second valve to beopened; causing the first valve to be closed; and determining that thesecond fluid flow path is associated with the blockage condition basedat least in part on determining that a third pressure data obtained whenthe second valve is open and the first valve is closed satisfies a thirdblockage threshold.
 72. The method of claim 71, further comprising, bythe controller: determining that the second fluid flow path isassociated with the blockage condition based at least in part on adetermination that the third pressure data measured when the secondvalve is open and the first valve is closed satisfies a third blockagethreshold.
 73. The method of claim 72, wherein the third blockagethreshold corresponds to an expected negative pressure of a single fluidflow path that is not associated with the blockage condition.
 74. Themethod of claim 67, wherein the plurality of fluid flow paths furthercomprises a third fluid flow path including a third valve, wherein thesecond pressure data is obtained when the first valve is open, thesecond valve is closed, and the third valve is closed, and wherein saididentifying comprises determining that the first fluid flow path isassociated with the blockage condition based at least in part on thesecond pressure data.
 75. The method of claim 67, further comprising, bythe controller: while the first valve remains open, cause the secondvalve to be closed; and determine that the first fluid flow path isassociated with the blockage condition based at least in part on adetermination that the second pressure data measured when the firstvalve is open and the second valve is closed satisfies a second blockagethreshold.
 76. The method of claim 67, further comprising, by thecontroller: determining that the second fluid flow path is notassociated with the blockage condition based at least in part on adetermination that the third pressure data measured when the secondvalve is open and the first valve is closed does not satisfy a thirdblockage threshold, wherein the third blockage threshold corresponds toan expected negative pressure of a single fluid flow path that is notassociated with the blockage condition.
 77. The method of claim 67,wherein the plurality of fluid flow paths further comprises a thirdfluid flow path configured to fluidically connect a third wound dressingto the negative pressure source, the third fluid flow path including athird valve, wherein when open the third valve allows passage of fluidthrough the third fluid flow path, and wherein when closed the thirdvalve blocks passage of fluid through the third fluid flow path.
 78. Themethod of claim 67, wherein the second pressure data is measured whenthe first valve is open, the second valve is closed, and the third valveis closed, and wherein the identification of the at least one fluid flowpath comprises the controller being configured to determine that thefirst fluid flow path is associated with the blockage condition based atleast in part on the second pressure data.
 79. The method of claim 67,further comprising, by the controller: while the first valve remainsopen: causing the second valve to be closed; causing the third valve tobe closed; and determining that the first fluid flow path is associatedwith the blockage condition based at least in part on a determinationthat the second pressure data measured when the first valve is open andthe second and third valves are closed satisfies a second blockagethreshold, wherein the second blockage threshold corresponds to anexpected negative pressure of a single fluid flow path.
 80. The methodof claim 67, further comprising, by the controller: causing the firstvalve to be closed; causing the second and third valves to be closed;and determining that at least one of the second fluid flow path or thethird fluid flow path is associated with the blockage condition based atleast in part on third pressure data measured when the first valve isclosed and the second and third valves are open.
 81. The method of claim67, further comprising, by the controller: while first valve remainsclosed and the second valve remains opened: causing the third valve tobe closed; and determining that the third fluid flow path is associatedwith the blockage condition based at least in part on fourth pressuredata measured when the first and second valves are closed and the thirdvalve is open.
 82. A method of operating a negative pressure woundtherapy device, the method comprising: closing a first valve associatedwith a first fluid flow path, the first fluid flow path configured toprovide fluidic connection between a negative pressure source and afirst wound dressing, wherein closing the first valve blocks flow offluid in the first fluid flow path; opening a second valve associatedwith a second fluid flow path, the second fluid flow path configured toprovide fluidic connection between the negative pressure source and asecond wound dressing, wherein opening the second valve allows flow offluid in the second fluid flow path; determining an operating conditionassociated with the second fluid flow path based at least in part on ameasured pressure in the second fluid flow path; and providingindication of the operating condition.
 83. The method of claim 82,wherein the operating condition associated with the second fluid flowpath comprises blockage in the second fluid flow path.
 84. The method ofclaim 82, further comprising, in response to determining blockage in thesecond fluid flow path: closing the second valve and opening the firstvalve; and providing an indication to replace the second dressing. 85.The method of claim 82, further comprising a third fluid flow pathconfigured to provide fluidic connection between the negative pressuresource and a third wound dressing, the third fluid flow path comprisinga third valve configured to provide fluidic connection between thenegative pressure source and the third wound dressing, wherein closingthe third valve blocks flow of fluid in the third fluid flow path.
 86. Amethod of operating a negative pressure wound therapy system, the methodcomprising: opening a first valve associated with a first fluid flowpath, the first fluid flow path configured to provide fluidic connectionbetween a negative pressure source and a first wound dressing, whereinclosing the first valve blocks fluid flow in the first fluid flow path;closing a second valve associated with a second fluid flow path, thesecond fluid flow path configured to provide fluidic connection betweenthe negative pressure source and a second wound dressing, whereinopening the second valve allows fluid flow in the second fluid flowpath; closing a third valve associated with a third fluid flow path, thethird fluid flow path configured to provide fluidic connection from anegative pressure source to a third wound dressing, wherein closing thethird valve blocks fluid flow in the third fluid flow path; anddetermining presence of a blockage in the first fluid flow path based atleast in part on a measured pressure in the first fluid flow path; upona determination of the blockage in the first fluid flow path: closingthe first valve, wherein closing the first valve blocks the flow offluid in the first fluid flow path, opening the second and third valves,wherein opening the second and third valves allows flow of fluid in thesecond and third fluid flow paths, determining presence of a blockage inat least one of the second or third fluid flow paths, in response todetermining that there is no blockage in the second and third fluid flowpaths, providing an indication to a user to replace the first wounddressing, and in response to determining that there is blockage in atleast one of the second or third fluid flow paths, provide indication tothe user.